Stockwinners Market Radar for January 08, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:10 EST Cathie Wood's ARK Investment bought 58K shares of Qualcomm today

20:09 EST Alcoa confirms curtailment of Kwinana Alumina Refinery in Western Australia - Alcoa "announced it plans to fully curtail production in 2024 at its Kwinana Alumina Refinery in Western Australia, with the process beginning in the second quarter. The Kwinana refinery has an annual nameplate production capacity of 2.2 million metric tons. The refinery has been operating at approximately 80 percent of its nameplate capacity since January of 2023."

19:00 EST Ironwood announces publication of Phase III study in The Lancet - Ironwood Pharmaceuticals announced that new data from the Phase III study that evaluated linaclotide in children and adolescents aged 6-17 years with functional constipation were published in The Lancet Gastroenterology & Hepatology. The data highlights additional efficacy endpoints from the company's pivotal Phase III trial, which formed the basis of the June 2023 U.S. Food and Drug Administration approval of linaclotide for the treatment of functional constipation in this population. Functional constipation in children is defined as a condition with hard, infrequent bowel movements that are often difficult or painful to pass. The condition affects an estimated 6 million children aged 6-17 years in the U.S. "Functional constipation is among the most common complaints pediatricians and pediatric GIs see in our patients," said Miguel Saps, Chief of Division of Pediatric Gastroenterology, Hepatology, and Nutrition and the George E. Batchelor Endowed Chair in Pediatrics, University of Miami, University of Miami Health System. "The insights provided by the additional efficacy endpoints in this Phase III clinical trial are an important supplement to clinicians' knowledge about the available treatment options for this population."

18:35 EST FDA says it cannot approve Astellas BLA for zolbetuximab by PDUFA action date - Astellas Pharma announced the U.S. Food and Drug Administration (FDA) issued a complete response letter on January 4, 2024, regarding the Biologics License Application (BLA) for zolbetuximab, an investigational agent for the treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. The FDA stated that the agency cannot approve the BLA by the Prescription Drug User Fee Act (PDUFA) action date of January 12, 2024, due to unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab. The FDA has not raised any concerns related to the clinical data, including efficacy or safety, of zolbetuximab, and is not requesting additional clinical studies. Astellas is working closely with the FDA and the third-party manufacturer to establish a timeline to quickly resolve the agency's feedback. No other Astellas products are affected.

18:01 EST PetMed Express names Leslie Campbell as chairman of the Board - PetMed Express announces the appointment of Leslie C. G. Campbell as Chairman of the Board effective January 5, 2024, as part of the company's ongoing Board composition and succession planning.

17:34 EST Plains All American raises quarterly dividend to 31.75c from 26.75c per share - The dividend will be payable on February 14, 2024 to holders of the respective securities at the close of business on January 31, 2024.

17:08 EST Healthcare Realty Trust completes $338M of asset sales during Q4 - Healthcare Realty Trust announced the completion of $338M of asset sales during the fourth quarter of 2023 bringing full year additional dispositions to $656M at an average cap rate of 6.6%. The full year additional dispositions resulted in proceeds of $597M as well as $59M of seller financing across three transactions, including $14M of seller financing in the fourth quarter. Proceeds were used for general corporate purposes, including the funding of development commitments and repayment of debt. The Company had no outstanding balance on its revolving credit facility as of December 31...The 2023 additional dispositions of $656M do not include the $112.5 M of asset sales in January 2023 that fully repaid the July 2022 merger-related special dividend.

16:56 EST Toll Brothers director sells $997K in common stock - In a regulatory filing, Toll Brothers disclosed that its director Paul Shapiro sold 10K shares of common stock on January 5th in a total transaction size of $997K.

16:41 EST Denny's enters exclusive test agreement with Franklin Junction - Denny's Corporation has entered an expansive agreement with Franklin Junction," the global leader in branded virtual restaurants."The agreement provides that Franklin Junction will partner with at least 250 domestic Denny's restaurants providing geographic exclusivity for these restaurants to accelerate Denny's market presence through its innovative Host Kitchen platform. "Our off-premises sales channels are a unique strength for Denny's, and we are excited about the opportunity to further advance our leadership position in the market," said Kelli Valade, Denny's President and Chief Executive Officer. "This new partnership with Franklin Junction will allow us to deliver even more amazing guests experiences." "We are excited to collaborate with Denny's to host new virtual concepts through their vast restaurant footprint," said Rishi Nigam, CEO and Co-Founder of Franklin Junction. "With our groundbreaking Host Kitchen platform, we are revolutionizing the way restaurants expand market share, and this relationship marks an exciting milestone in our mission to redefine restaurant economics and the future of dining."

16:36 EST Unity announces 25% workforce reduction - In a regulatory filing, Unity announced that it plans to reduce approximately 1,800 employee roles, or approximately 25% of its current workforce, as it restructures and refocuses on its core business, and to position itself for long-term and profitable growth. At this time, Unity cannot reasonably estimate the costs and charges in connection with this reduction, which it expects will be substantially incurred in the first quarter of 2024. The charges will primarily relate to employee transition, severance payments, and employee benefits.

16:32 EST HashiCorp names Michael Weingartner CPO, promotes Talha Tariq to CIO and CSO - HashiCorp announced that Michael Weingartner has joined HashiCorp as its first chief product officer, or CPO, and that Talha Tariq has been promoted to chief information officer, or CIO, and chief security officer, or CSO. Effective immediately, Weingartner and Tariq will both report to HashiCorp CEO Dave McJannet. In the newly created role, Weingartner will lead HashiCorp's R&D organization, where he will manage day-to-day operations and execution of the overall research and development product strategy across HashiCorp's entire product suite. Armon Dadgar will continue in his role as chief technology officer, where he interacts daily with HashiCorp customers and partners.

16:32 EST Extreme Networks says Q2 outlook reflects industry channel digestion - CEO Ed Meyercord stated: "Our revised second fiscal quarter outlook reflects industry headwinds of channel digestion and elongated sales cycles. In late Q2, we saw multiple large deals pushing out to future quarters. We remain confident in our long-term strategy and our ability to achieve double-digit long-term revenue and EPS growth supported by competitive customer wins and the growth in our opportunity funnel. In addition, we've made significant progress advancing our strategic initiatives to launch our managed services commercial platform and unique subscription offering to large service providers."

16:18 EST Zumiez total net sales decreased 4.4% for nine-week 'holiday' period YoY - Zumiez announced that the Company's total net sales decreased 4.4% for the nine-week period ended December 30, compared to the nine-week period ended December 31, 2022. During the same period comparable sales decreased 5.9%. From a regional perspective, quarter-to-date North America net sales decreased 6.6% from the prior year with comparable sales over this period down 6.3%. Other international net sales, which consists of Europe and Australia, increased 4.2% quarter to date with comparable sales down 4.2% over the same period. Excluding the impact of foreign currency translation, North America net sales decreased 6.6% and other international net sales increased 0.8% for the nine-week period compared to the prior year. During the nine-week period, men's posted positive comparable sales while all other categories were down in comparable sales from the prior year with Women's being the most negative category, followed by Hardgoods, accessories and Footwear.

16:17 EST Eversource expects to record after-tax impairment charge of $1.4B-$1.6B in Q4 - Eversource Energy provided the following updates regarding its process to divest its 50% ownership interest in three offshore wind projects: South Fork Wind, Revolution Wind and Sunrise Wind. Eversource currently holds its share of these three projects in two separate joint venture partnerships with Orsted, one that holds only South Fork Wind and another that holds both Revolution Wind and Sunrise Wind. Eversource also separately holds a tax equity investment in South Fork Wind. As a result of these fourth quarter developments, Eversource expects to record an after-tax other-than-temporary impairment charge in the range of $1.4B to $1.6B in the fourth quarter of 2023. This range is an estimate and subject to change as Eversource prepares its financial statements for the year ended December 31, 2023. The impairment charge reflects the current estimate of the fair value of the projects and will not impact Eversource's future cash flows or its current cash balances. Eversource will continue to make future cash expenditures for required cash contributions to the JV projects up to the time of the sale of its interest in these projects.

16:16 EST Urban Outfitters reports holiday sales increased 10% - Urban Outfitters announced net sales for the two and eleven months ended December 31, 2023. Total company net sales for the two months ended December 31, 2023, increased 10% compared to the two months ended December 31, 2022. Total Retail segment net sales increased 8%, with comparable retail segment net sales increasing 6%. The increase in retail segment comparable net sales was driven by high single-digit positive growth in digital channel sales and low single-digit positive growth in retail store sales. Comparable retail segment net sales increased 20% at Free People and 14% at Anthropologie and decreased 13% at Urban Outfitters. Wholesale segment net sales increased 15% driven by an increase in Free People wholesale sales primarily due to increases in sales to department stores and specialty accounts, partially offset by a decrease in Urban Outfitters wholesale sales. Nuuly segment net sales increased 71% primarily driven by a 58% increase in our subscribers versus the end of the prior year's comparable period. For the eleven months ended December 31, 2023, total company net sales increased 8% compared to the eleven months ended December 31, 2022. Total retail segment net sales increased 6%, with comparable retail segment net sales increasing 5%. The increase in retail segment comparable net sales was driven by high single-digit positive growth in digital channel sales and mid single-digit positive growth in retail store sales. Wholesale segment net sales decreased 4%, driven by a decrease in Free People wholesale sales primarily due to a decrease in sales to department stores. Nuuly segment net sales increased 92% primarily driven by a 58% increase in our subscribers versus the end of the prior year's comparable period. On a personnel note, the company announced Shea Jensen will be joining Urban as president of Urban Outfitters Brand, North America as of February 5. In this role, Shea will oversee merchandising, marketing, digital and retail operations for the Urban Outfitters brand in North America.

16:06 EST Nuvation Bio announces FDA clearance of IND application for NUV-1511 - Nuvation Bio announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-1511, the first clinical candidate from the company's novel drug-drug conjugate (DDC) platform. "This IND clearance expands our clinical pipeline and validates the approach of our proprietary DDC platform to design potent oncology-focused chimeric small molecules which combine tumor-targeting specificity with the anti-cancer activity of known oncology agents," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We believe NUV-1511 has the potential to provide favorable clinical benefit for patients with various solid tumors and we look forward to initiating the Phase 1/2 study."

16:01 EST Bark backs Q3 adjusted EBITDA view ($8M)-($5M)

16:00 EST nVent Electric names Martha Claire Bennett as Chief Marketing Officer - nVent Electric announced Martha Claire Bennett has joined the organization as Executive Vice President and Chief Marketing Officer. Bennett brings more than 25 years of global marketing experience with strong expertise in omnichannel marketing, brand management and vertical strategy. She most recently served as CMO and SVP of 3M's Safety and Industrial Business Group, where she led the global marketing function and broader community of marketing practice for the company's largest business group.

14:56 EST Bausch + Lomb CFO says 2024 'an investment year' - Speaking during the JPMorgan Healthcare Conference earlier, Bausch + Lomb CFO Sam Eldessouky said in part: "I echo what [CEO] Brent [Saunders] said when -- I looked at many of the models out there, and I think you've done a nice job with how you thought about 2024 for us. And really the key comes down to if you start from the top line, you're starting down with how we think about the growth in the business, and we always said that we're going to be growing at or above market. So think about it. The markets are around the mid-single digits. But also the key decision, and that's part of the comments that we made in the last earnings call, was we're early days in the MIEBO launch, and we're early days. We're just closing in our transaction with XIIDRA. And we knew that based on the early data that we've seen, that there was something good with us, and we wanted to make sure that we're going to continue to invest behind it. So when you think about 2024 for us, it's an investment year. That's how I think about it. There's -- yeah. I think Brent mentioned it also in the last earnings call. This is our highest number of launches we've had in B + L history. So we're going to fuel those launches with investments. And as you start thinking about the margin, it is not going to be a lift, immediate lift from a year-to-year basis. It's going to be a steady growth of margin as you go forward." In afternoon trading, Bausch + Lomb shares are down 71c, or 4%, to $15.68.

13:56 EST New Panasonic smart TVs to carry Fire TV as operating system starting in 2024 - Starting in 2024, Panasonic (PCRFY) smart TVs will come with Amazon (AMZN) Fire TV built in. Panasonic announced a global collaboration with Amazon that will introduce new Panasonic smart TVs that carry Fire TV as its operating system starting this year. To kick off this collaboration, Panasonic unveiled two new flagship OLED TVs for 2024, the Z95A -- 65 inches and 55 inches -- and Z93A -- 77 inches -- smart TVs with Fire TV built in.Reference Link

13:27 EST AAR says did not perform work on 737 MAX 9 mid-cabin exit door plug - AAR Corp. said it learned of the recent incident impacting the mid-cabin exit door plug of an Alaska Airlines Boeing 737 MAX 9 on January 5, that resulted in an emergency landing of the aircraft. The company said in a statement: "AAR did not perform any work on or near any mid-cabin exit door plug of that specific aircraft. AAR was contracted by Alaska Airlines to perform a 2KU Modification (Wi-Fi modification) on the aircraft that was performed from November 27 to December 7, 2023."

13:02 EST Edgewise, Caribou higher after WSJ report of Cytokinetics buyout

12:49 EST Mountain Crest Acquisition Corp IV trading resumes

12:44 EST Insulet recalls Omnipod 5 Android app over software error, FDA says - The FDA announced that Insulet recalled its Omnipod 5 Android app due to a software error when the user enters a bolus amount less than 1 unit without putting a leading zero before the decimal point. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death, the agency said in a statement. Due to this error, when entering a bolus dose of insulin less than 1 unit, the SmartBolus calculator does not register the decimal point if it is the first character entered. There have been 2 reported injuries. There have been no reports of death. Reference Link

12:40 EST Medtronic announces FDA approval of Percept RC DBS system - Medtronic announced the Food and Drug Administration approval of its Percept RC Deep Brain Stimulation system. The Percept family is the only sensing-enabled deep brain stimulation system on the market, allowing the physician to personalize treatment for patients with movement disorders such as Parkinson's disease, essential tremor, and dystonia as well as epilepsy, the company said in a statement.

12:14 EST Mountain Crest Acquisition Corp IV trading halted, volatility trading pause

12:04 EST Bit Brother Limited anounces 1-for-1,000 reverse share split - Bit Brother announced that a 1 for 1,000 reverse split of its Class A ordinary shares and Class B ordinary shares was approved by the Company's board of directors on November 14, 2023 and is expected to become effective on or around January 10, 2024. Upon the effectiveness of the reverse share split, Bit Brother shareholders will receive one new Class A ordinary share of Bit Brother for every thousand shares they hold. Bit Brother's Class A ordinary shares are expected to begin trading on a split-adjusted basis when the market opens on January 10, 2024. The reverse share split is expected to lead Bit Brother's Class A ordinary shares to trade at approximately one thousand times the price per share at which it trades prior to the effectiveness of the reverse share split. Bit Brother, however, cannot assure that the price of its Class A ordinary shares after the reverse split will reflect the 1 for 1,000 reverse split ratio, that the price per share following the effective time of the reverse split will be maintained for any period of time, or that the price will remain above the pre-split trading price. There will be no changes to Bit Brother's Amended and Restated Articles and Memorandum of Association in connection with the reverse share split. As of January 8, 2024, there were approximately 3.8 Billion of Bit Brother's Class A ordinary shares outstanding. Effecting the 1 for 1,000 reverse split will reduce that amount to approximately 3.8 Million Class A ordinary shares outstanding.

12:00 EST Bright Health falls -10.5% - Bright Health is down -10.5%, or -$1.20 to $10.27.

12:00 EST Solo Brands falls -36.6% - Solo Brands is down -36.6%, or -$2.16 to $3.74.

12:00 EST Unifi rises 12.5% - Unifi is up 12.5%, or 81c to $7.27.

11:58 EST Novartis to acquire Calypso Biotech for $250M upfront, up to $175M in milestones - Calypso Biotech BV, a spin-out from Merck (MRK) that identifies itself as "a leader in the development of Interleukin15 targeted therapies," announced that it has entered into an agreement to be acquired by Novartis AG (NVS). Calypso's shareholders will receive an upfront payment of $250M upon closing and are eligible to receive development milestones of up to $175M based on the achievement of certain predetermined milestones. Calypso is focused on the research and development of monoclonal antibodies for an array of autoimmune indications, with an expertise in IL-15 biology. "IL-15 is a broad, untapped immune axis that controls barrier function and downstream immune cascades in many chronic autoimmune diseases. Calypso's lead product candidate, CALY-002, is a potential best-in-class therapeutic antibody that binds to and neutralizes Interleukin-15," the company stated. "The acquisition gives Novartis full rights to CALY-002. Novartis intends to further explore CALY-002 across a wide variety of autoimmune indications with high unmet medical need. CALY-002 is currently evaluated in a Phase 1b trial in patients with Celiac Disease and Eosinophilic Esophagitis," the company added. Reference Link

11:50 EST SanReno Therapeutics acquired by Novartis - On January 5, SanReno Therapeutics, a clinical-stage company specializing in the discovery, development, and commercialization of innovative therapies for kidney diseases, announced its acquisition by Novartis. Following the acquisition's closure, SanReno becomes an indirect, wholly-owned subsidiary of Novartis. The founding investors of SanReno, including Pivotal bioVenture Partners China, Frazier Life Sciences, Samsara BioCapital, and Versant Ventures, have sold their equity securities in SanReno, the company noted. "Established in late 2021 as a joint venture between the investor consortium and Chinook Therapeutics (now part of Novartis), SanReno holds exclusive rights in Greater China and Singapore for two late-stage assets targeting Immunoglobulin A Nephropathy: atrasentan and zigakibart. Atrasentan, an oral endothelin A receptor antagonist, is presently undergoing Phase 3 development for IgAN. It demonstrated clinically meaningful and highly statistically significant proteinuria reduction at the 36-weeks interim analysis, successfully meeting the primary endpoint of its Phase 3 study. Zigakibart, a subcutaneously administered monoclonal antibody targeting APRIL - A Proliferation Inducing Ligand - obtained approval from China CDE for entry into the Phase 3 study in October 2023. Completed within the first two years of SanReno's formation, this acquisition is one of the few transactions where a Chinese biotech company has been acquired by a multinational pharmaceutical company. The transaction underscores China's substantial market potential within the global renal market and is in strategic alignment with the Novartis commitment to pioneering innovative therapies for kidney diseases," SanReno stated.

11:20 EST Bruker sees 'solid' organic revenue growth, adjusted EPS growth for FY24

11:19 EST Bausch Health reports Court of Appeals heard oral arguments on patent dispute - Bausch Health and its gastroenterology business Salix Pharmaceuticals announced that, as scheduled, oral arguments were heard today at the U.S. Court of Appeals for the Federal Circuit in the matter of "Salix Pharmaceuticals, LTD et al v. Norwich Pharmaceuticals, Inc." As expected, no ruling was issued by the Court following these oral arguments, the company stated. "We were pleased to have had the opportunity to present our oral arguments to the Court of Appeals today," Thomas Appio, Chief Executive Officer said. "We look forward to the Court's decision in due course. We will continue to advocate for the safety of patients who have benefited from continued access to XIFAXAN, and look forward to continuing to serve those patients."

11:02 EST Cerence to partner with VW on 'automotive-grade ChatGPT integration' - Cerence (CRNC) and Volkswagen (VWAGY) announced that they are partnering to deliver "a uniquely intelligent, automotive-grade ChatGPT integration to Volkswagen drivers." The companie said: "Volkswagen will leverage Cerence's new, generative AI-powered Cerence Chat Pro to enable drivers and passengers to engage the in-car assistant in fun and conversational chit-chat, leveraging a multitude of sources, including ChatGPT, to provide accurate and relevant responses to nearly every query imaginable... Looking toward the future, Volkswagen and Cerence will explore collaboration to design a new, large language model-based user experience as the basis of Volkswagen's next-generation in-car assistant. This unique user experience will combine voice and touch, allowing users to perform tasks across different applications in a single conversational thread for a safer and more joyful driving experience. The system will be built on Cerence's first-of-its-kind, automotive-grade LLM fine-tuned with the company's extensive automotive dataset."

10:51 EST Bristol Myers sees low to mid single digit revenue CAGR 2020-2025 - Sees low double digit revenue CAGR ex-Rev/Pom from 2020-2025. Sees $8B-$10B growth from in-line brands from 2020-2025. Sees more than $10B revenue from new product portfolio in 2026. Sees operating margin target more than 37% through 2025. Sees $25B NRA for nine new product portfolio in 2030. Comments taken from investor presentation slides.

10:47 EST TXU Energy enters multi-year partnership with University of Houston system - TXU Energy has entered a multi-year partnership to provide electricity to the entire University of Houston System, including all four university campuses, all UH instructional sites, and more than a dozen athletic facilities and venues. The contract is designed to meet the unique needs of a system serving more than 75,000 students, with an investment in scholarships and significant rebates for energy efficiency projects.

10:35 EST Palatin provides corporate update, outlines CY24 milestones - Palatin Technologies provided a corporate update, highlighted the company's key calendar year 2023 accomplishments and outlined its anticipated calendar year 2024 clinical development milestones. "We made significant operational progress during calendar year 2023 and we believe we are well-positioned for making calendar year 2024 a pivotal and transformative year for Palatin," said Carl Spana, Ph.D., President and CEO of Palatin. "Our internal research and development efforts are focused in areas where we believe we have a high probability of success, product differentiation and the opportunity for a substantial return on our investment. Topline data readout for our Phase 3 PL9643 clinical study for DED is expected early in the first quarter of calendar year 2024. Our Phase 2 study of oral PL8177 in patients with UC is expected to have an interim analysis data readout in the first quarter and topline trial results in the second quarter of calendar year 2024." Dr. Spana further commented, "We are excited by the significant opportunity of melanocortin-based therapeutics for obesity treatment and believe we are well positioned to deliver selective and efficacious MCR4 long-acting peptides and orally active small molecules. We expect to commence a Phase 2 clinical study of a MCR4 agonist plus a GLP-1 in obese patients in the first quarter of calendar year 2024. In addition, following on our significant expertise in product development to treat sexual dysfunction, we expect to commence a Phase 2 clinical study evaluating bremelanotide co-formulated with a PDE5i for the treatment of ED in patients that do not respond to PDE5i monotherapy in the first quarter of calendar year 2024."

10:32 EST AMD unveils AMD Radeon RX 7600 XT graphics card - Ahead of CES 2024, AMD introduced the AMD Radeon RX 7600 XT, a "high-performance, feature-rich graphics card designed to power demanding games and content creation applications today and for years to come. The AMD Radeon RX 7600 XT graphics card is an ideal upgrade solution for gamers, offering fast, smooth, and visually stunning gaming and raytracing experiences at 1080p and beyond. Additionally, featuring 16GB of high-speed GDDR6 memory it unleashes users' creativity in next-gen AI and content creation workloads."

10:05 EST Prothena remains on track with partnered programs, provides updates - Prothena Corporation earlier provided a business update on portfolio programs. PRX012, a wholly-owned potential best-in-class, next-generation subcutaneous antibody for the treatment of AD that targets a key epitope at the N-terminus of amyloid beta with high binding potency. The U.S. FDA has granted Fast Track Designation for PRX012 for the treatment of AD. Ongoing Phase 1 trial continues as planned and expect to update in 2024. BMS-986446, a potential best-in-class antibody for the treatment of AD that specifically targets a key epitope within the microtubule binding region of tau, a protein implicated in the causal human biology of AD. BMS-986446 is part of a Global Neuroscience Research and Development Collaboration with Bristol Myers Squibb (BMY). Bristol Myers Squibb reported that Phase 1 data supports rapidly moving BMS-986446 into a Phase 2 clinical trial in 1H 2024. A Phase 1 timeline update for PRX123 is expected in 2024 in order to optimize capital allocation across robust clinical portfolio. Roche (RHHBY) completed enrollment for the Phase 2b PADOVA clinical trial in patients with early PD; topline results expected in 2024. Patient enrollment remains on track for Birtamimab and a re-estimation, based on a predetermined number of mortality events, has full topline study results expected between 4Q 2024 and 2Q 2025. An interim analysis for overwhelming efficacy will be performed when approximately 50% of the events have occurred. At December 31, 2023, Prothena had cash, cash equivalents, and restricted cash of approximately $621M. Cash on hand provides sufficient capital which takes Prothena beyond the completion of its ongoing clinical trials.

10:00 EST Scor ADR rises 8.5% - Scor ADR is up 8.5%, or $1.68 to $21.45.

10:00 EST Genesco falls -10.3% - Genesco is down -10.3%, or -$3.19 to $27.87.

10:00 EST Solo Brands falls -32.7% - Solo Brands is down -32.7%, or -$1.93 to $3.97.

09:52 EST VERB's MARKET.live adds five cosmetic brands to livestream shopping platform - Verb Technology Company announces the addition of five dynamic new brands favored by the 'U40' demographic.Meet the Newest Additions to MARKET.live: Planet Beauty; Half Cakes; Gunas; Gleam Eyewear; Johnny Fly.

09:47 EST Spirit AeroSystems falls -13.9% - Spirit AeroSystems is down -13.9%, or -$4.41 to $27.32.

09:47 EST Genesco falls -17.7% - Genesco is down -17.7%, or -$5.49 to $25.57.

09:47 EST ProShares UltraShort Bloomberg Natural Gas rises 8.0% - ProShares UltraShort Bloomberg Natural Gas is up 8.0%, or $6.09 to $82.39.

09:47 EST Inspire Medical rises 10.4% - Inspire Medical is up 10.4%, or $18.34 to $193.99.

09:41 EST Cardio Diagnostics announces grant of patent in India - Cardio Diagnostics announced that India's Patent Office has granted a patent to the University of Iowa Research Foundation, or UIRF, under patent number 484488, titled "A Kit for Determining Methylation Status of a CpG Dinucleotide and a Genotype of a Single Nucleotide Polymorphism." The patent was exclusively licensed to the Company from the University of Iowa Research Foundation, or UIRF. It was co-invented by Cardio Diagnostics' founders, Meesha Dogan and Robert Philibert, the CEO and chief medical officer of the Company, respectively.

09:37 EST Garmin to provide motorcycle infotainment solutions to Yamaha Motor - Garmin (GRMN) will provide infotainment systems to select Yamaha (YAMHF) motorcycles and smart scooters. Featuring Bluetooth connectivity, media integration and enhanced navigation functionality, the Garmin Automotive OEM solutions will support Yamaha Motor's Connected Vision program that seeks to attain 100% vehicle connectivity.

09:35 EST Caterpillar, CRH announce strategic agreement for electric off-highway trucks - Caterpillar (CAT) announced it has signed an electrification strategic agreement with CRH (CRH) to advance the deployment of Caterpillar's zero-exhaust emissions solutions. "CRH is the number one aggregates producer in North America and the first company in that industry to sign such an agreement with Caterpillar. The agreement is focused on accelerating the deployment of Caterpillar's 70 to 100-ton-class battery electric off-highway trucks and charging solutions at a CRH site in North America. Through the agreement, CRH will participate in Caterpillar's Early Learner program for battery electric off-highway trucks, testing and validating the units in real-world applications. CRH will also provide voice of customer feedback to address safety, performance, operational and compliance requirements for the aggregates industry," the company stated.

09:30 EST Terreno Realty acquires industrial property in Washington for $6.5M - Terreno Realty acquired an industrial property located in Bellevue, Washington on January 5 for a purchase price of approximately $6.5M. The property consists of one industrial distribution building containing approximately 16,000 square feet on 1.8 acres. The property is vacant and the estimated stabilized cap rate is 5.8%.

09:29 EST Tecogen launches self-learning intelligent control for cogeneration systems - Tecogen announced that Tecogen has been developing and testing machine learning based intelligent control for cogeneration and cooling systems. The system self-learns from data on our remote monitoring platform CHPInsight and determines the optimum way to operate a chiller or cogeneration plant based on a building's seasonal load profile. Testing on a selection of customer sites has resulted in reduced energy purchased from the utility and an increase in equipment run hours. This is a benefit for the customer and Tecogen as it increases customer savings and Tecogen's service revenue. We expect to start implementing this in many of our service sites over the course of this year. Any cogeneration system connected to our platform can be controlled centrally. This will also allow us to act like a virtual power plant and participate in utility demand response programs. The capacity from multiple cogeneration systems can be aggregated and receive utility payments which can be shared with the customer. Since the self-learning intelligent control system is built on our remote monitoring platform it can also be integrated with other distributed generation and cooling products.

09:28 EST PTC Therapeutics announces 2024 potential key clinical, regulatory events - Submission of a MAA to the EMA for sepiapterin for the treatment of PKU is expected in the first quarter. Submission of an NDA to the FDA for sepiapterin for the treatment of PKU is expected no later than the third quarter. Results from 12-month interim data from the PIVOT-HD trial of PTC518 in HD patients are expected in the second quarter. Submission of a BLA to the FDA for Upstaza for the treatment of AADC deficiency is expected in the first quarter. Topline results from the CardinALS trial of utreloxastat in ALS are expected in the fourth quarter. PTC expects the CHMP opinion from the re-examination procedure of the negative opinion on the Translarna conditional marketing authorization renewal in late January 2024, with ratification of that opinion by the European Commission 67 days later. FDA meeting for Translarna to align on the specific contents of a potential NDA resubmission is scheduled for the first quarter. FDA meeting for vatiquinone to discuss how the MOVE-FA data along with additional clinical and preclinical data could support an NDA submission in FA is scheduled for the first quarter. Scientific advice feedback from the EMA on a potential submission of vatiquinone for conditional marketing authorization for Friedreich ataxia is expected in the first quarter.

09:27 EST Round Table Pizza debuts in Oklahoma, Arizona - FAT Brands announces a new development deal set to bring the Round Table Pizza chain to Oklahoma and Arkansas. The new deal will bring a total of 10 Round Table Pizza franchised restaurants to Oklahoma and an additional six franchised locations to Arkansas over the next six years.

09:26 EST Vicinity Motor announces VMC 1200 distribution agreement with Shift EV - Vicinity Motor has signed a new distribution agreement with Shift EV Trucks to open Vicinity Trucks West Toronto, a new VMC specific dealership, by the owners of the successful Shift Electric Vehicles for the West Toronto territory. Shift Electric Vehicles has been offering a wide selection of premium electric vehicles online or in its showroom since 2013 in Oakville, Ontario - between Toronto and Hamilton. The dealership offers a complete range of EV cars, trucks and motorcycles across a variety of brands and is equipped with a Service department for electric vehicles of all makes and models. Owner Paul Repar has a robust automotive and transportation career spanning over 30 years, previously holding positions with Ford, Volvo, Mercedes-Benz and BMW Canada. With the opening of Vicinity Trucks West, Shift EV Trucks will provide fleet solutions for businesses and government with its inventory of Vicinity vehicles. Per the terms of the agreement, Vicinity Trucks West Toronto will distribute Vicinity VMC 1200 trucks throughout Western Toronto. This agreement will further supplement Shift's portfolio of electric vehicles with a dedicated commercial EV.

09:25 EST Janover launches its insurtech startup, Janover Insurance Group - Janover announced that it has launched a new insurtech as a wholly owned subsidiary, Janover Insurance Group. This new venture is set to seamlessly integrate with Janover's powerful generative AI applications and directly plug into its industry-leading marketing funnel. By leveraging Janover's marketing funnel, which has over 88 million annual impressions on Google, Janover Insurance Group is expected to immediately gain broad distribution and enhance operational efficiencies. "Our entrance into insurtech with Janover Insurance Group signifies a pivotal step on our ongoing journey to improve financial services for commercial real estate and SMB enterprises by building best in class, tech first solutions where they are most needed," said Blake Janover, Chairman and CEO of Janover Inc. "We believe that this specialized insurtech arm is the ideal product to add to our ecosystem as it solves a meaningful pain point in the market and leverages technology and systems we've already built. Our expertise in the practical application of generative AI and building marketplaces, combined with our robust marketing capabilities, positions us uniquely to redefine the commercial insurance space and offer unparalleled service to our clients. It further creates an end-to-end tech-first financial services firm for our customers; further enhancing our revenue with recurring, predictable income. By strengthening our financial foundation, we will be able to better service our customers as we continue to scale."

09:24 EST HNR Acquisition announces 2024 operational plan - Over 45 days ago, the Company completed the acquisition of its interest in the Grayburg-Jackson oil field in Eddy County, New Mexico. The field operates 550 oil and gas wells on 13,700 contiguous acres. The Grayburg-Jackson field began development in the 1940's and in 2020 started to waterflood the Seven Rivers interval with good results. The revenues have grown ever since 2020 and the field has been profitable with positive cash flow for the last two years. LH Operating, a wholly owned subsidiary in the Company structure acquired in November 2023, had $20.3 million of revenues generating positive cash flow and $3.9 million of net income for the nine months ended September 30, 2023. These results included the historical lift costs of $17.00 per barrel. With the acquisition now completed, HNRA will report its first consolidated financials for the fiscal year ended December 31, 2023, which will include results from the acquisition for six weeks of the fourth quarter. HNRA has performed an initial analysis of the field in conjunction with the results of the pilot study and subsequent actions. To improve capital expenditure efficiency the Company intends to fine-tune its 7R waterflood completions and pumping methods. The Company believes this approach has a high probability of success.

09:23 EST Royalty Management announces update on magnet materials program - Royalty Management Holding is pleased to provide an update to its investment in a state-of-the-art permanent magnet materials program with Advanced Magnet Lab. The sponsorship is focused on the stand up of lab-scale capabilities for the development of proprietary metal alloy compositions that are used in the manufacturing of permanent magnets. The strategic partnership between RMCO and AML began in December 2022, when RMCO engaged with AML to fund the setup and development of a pilot-scale lab for producing novel metal alloys compositions for producing magnet powder. This relationship also provides RMCO with a royalty interest in these novel compositions developed that are consumed in producing permanent magnets. The collaboration between RMCO and AML, with the pilot-scale lab, is expected to begin producing sintered and non-sintered magnet alloy samples in the first half of 2024 for prototyping with AML's PM-Wire process. RMCO and AML will continue to explore further business opportunities, including, but not limited to, additional material development programs and the commercial scale-up of metal alloys production capabilities. RMCO has funded this effort through an investment in AML with subscription to convertible notes under the AML 2022 Convertible Note Round.

09:22 EST Biomea Fusion doses first patient with type 1 diabetes in COVALENT-112 trial - Biomea Fusion announced dosing of the first patient with type 1 diabetes in the U.S. in its ongoing Phase II study, COVALENT-112, evaluating BMF-219, a novel, investigational covalent menin inhibitor, as a potential treatment for patients with type 1 diabetes. "We are very excited to announce this milestone of starting the enrollment in our clinical trial for adults with type 1 diabetes, where a great unmet need exists. Persons with type 1 diabetes require exogenous insulin therapy, which entails intensive management and can result in important morbidity, including hypoglycemia and weigh gain. With the encouraging data from our preclinical and early-phase clinical studies of BMF-219 in type 2 diabetes, we believe that by targeting one of the root causes of diabetes, this oral agent has the potential to restore the health and function of the body's own mechanism to produce insulin, the beta cells," stated Juan Pablo Frias, MD, Biomea Fusion's Chief Medical Officer. He added, "We look forward to presenting initial data in 2024 as we march toward our goal of delivering a transformational therapy for patients with diabetes."

09:20 EST MGP Ingredients promotes Pasagic to Chief Commercial Officer - MGP Ingredients announces the promotion of Amel Pasagic to the newly created position of Chief Commercial Officer, effective today. As Chief Commercial Officer, Pasagic will be responsible for all commercial activities across MGP's three business segments. Pasagic joined MGP as Vice President, Information Technology, when the company acquired Luxco, Inc. and its affiliated companies in April 2021.

09:18 EST Twilio CEO Jeff Lawson to step down, Khozema Shipchandler to succeed - Twilio announced that Khozema Shipchandler, formerly president of Twilio Communications, has been appointed CEO and will join the company's board of directors, effective immediately. Shipchandler succeeds Jeff Lawson, Twilio's co-founder, who is stepping down as CEO and as a member of the Twilio board. In addition, Jeff Epstein, a member of the Twilio board and lead independent director since 2017, has been appointed as chair of the Twilio board.

09:17 EST CMC Metals acquires silver-gold polymetallic Gavilanes project - CMC Metals Ltd. announced that the Sailfish Royalty has entered into a share purchase option agreement with the Company that grants the option to acquire all of the issued and outstanding shares of Swordfish Silver Corp. Swordfish, through Sailfish de Mexico S.A. de C.V., holds the mineral rights of the Gavilanes silver exploration property located in the Municipality of San Dimas, State of Durango, Mexico. The terms of this agreement were previously announced in a press release dated December 21, 2023 with a majority of the financial commitments in the back-end of the multi-year deal. The deal is also subject to Exchange approval. The silver-gold polymetallic Gavilanes Project has a current NI 43-101 Inferred Resource of 18,174,000 contained silver-equivalent ounces at an average grade of 320.3 g/t Ag-Eq within 1,765,000 tonnes. The metal prices assumed in the resource estimate were $19.00 USD/oz silver, $1,600 USD/oz gold, $3.50 USD/lb copper, and $1.00 USD/lb for lead and zinc. Gavilanes is a low to intermediate sulfidation epithermal deposit and is located in the Sierra Madre Occidental Province in southwestern Durango. Limited drilling at the site has been completed over 0.2 square kilometers of veins. Gavilanes has been subjected to periodic episodes of drilling totalling 61 diamond drill holes. A majority of the drilling was completed by Santa Cruz Silver Mining. The drilling focused on the Guadalupe Solitude structure along only 500 meters. The San Nicolas mineralized structures, which span 2.6 kilometers, have only been tested over 250 meters with drilling intersecting an important gold system that was later confirmed with mapping and surface sampling.

09:15 EST JetBlue extends partnership with FLYR - FLYR, the AI-powered technology platform for travel, announced that JetBlue is extending its partnership with FLYR. The commercial agreement has been extended to continue to boost the airline's revenue optimization capabilities using decision intelligence powered by deep learning. Utilizing cutting-edge deep learning technology, FLYR's cloud-native decision intelligence platform, Flight Revenue Management, offers automated, AI-powered revenue management capabilities. Already in action at JetBlue, this system is proving its effectiveness in maximizing opportunities across the business, enabling quick, precise capacity plans and pricing adjustments. "We have a strong track record of challenging industry norms and reshaping established processes," said Dave Clark, Head of Revenue and Planning at JetBlue. "Our partnership with FLYR and commitment to its AI-driven software allows us to continue to offer our customers a low fare and great service."

09:14 EST Instacart to expand advertising solutions to Caper Carts - Instacart announced it is expanding its advertising solutions to Caper Carts, the company's AI-powered smart carts. Instacart will begin piloting ads on Caper Carts at Good Food Holdings banner stores, bringing personalized and dynamic recommendations into the physical aisles of the grocery store. Ads on Caper Carts will soon give customers more customized recommendations and introduce experiences to help them discover new brands and products. This first-of-its-kind advertising opportunity connects brands and retailers with customers directly in the aisles - who, on average, spend more than 30 minutes shopping in-store with a Caper Cart.

09:12 EST Scilex CEO issues letter to stockholders - Scilex Holding issued a letter from Jaisim Shah, its Chief Executive Officer and President, to its stockholders highlighting the Company's accomplishments in 2023 and its forward outlook for 2024. "I would like to express my deepest gratitude for your unwavering support, patience, and invaluable feedback throughout the transformative year in 2023. It is our hope that this communication serves as both a reflection on Scilex's significant strides in the past year and an insightful preview into the challenges and opportunities that lie ahead in 2024... As we continue to navigate the complexities of the pharmaceutical landscape, your role as stockholders in this journey is invaluable. Thank you for being an integral part of our mission and for your unwavering belief in our vision. Together, we are not just witnessing, but actively shaping, a pivotal chapter in healthcare history... We accomplished all of the goals that we set out at the beginning of 2023... Outlook for 2024... Despite the challenges that remain ahead, we are setting ambitious goals for the Company in 2024, including: Expected launch of Gloperba... Seek FDA approval for the modification of Gloperba... Continue to grow our gross sales with a goal of exceeding $200 million.Seek FDA approval of ELYXYB in acute pain in the U.S... Continue to develop our novel clinical pipeline... Initiation of ELYXYB pediatric study for migraine. Finalize plan with FDA for Phase 2/3 study for SP-103 in acute pain. Initiation of SP-102 chemistry, manufacturing and controls activities for commercial scale manufacturing for NDA filing in the U.S. File ZTlido applications in ex-US markets... Prepare for the next major international change affecting the demand for non-opioid therapeutics and be ready to capitalize on that change. Continue to enhance our product portfolio by in-licensing and out-licensing commercial products. Continue to enhance stockholder value and optimize our capitalization structure.... In closing, my heartfelt thanks go to the remarkable team at Scilex. Your unwavering dedication, creativity, and resilience are the driving forces behind our success. To our partners, our stockholders, and our dedicated board members: thank you for your confidence in us as we continue to forge ahead with our mission."

09:11 EST Janux Therapeutics promotes Tommy DiRaimondo to chief scientific officer - Janux Therapeutics announced the promotion of Tommy DiRaimondo to chief scientific officer. In his prior role as head of research, DiRaimondo was instrumental in successfully transitioning Janux's PSMA-TRACTr and EGFR-TRACTr programs from research into clinical trials.

09:10 EST Rekor Systems, Kistler partner on roadway intelligence - Rekor Systems announced its Urban Mobility division has unveiled a strategic collaboration with Kistler. This strategic alliance marks a significant leap forward in real-time and predictive roadway intelligence, squarely addressing the critical issue of bridge and roadway infrastructure deterioration caused by dangerous, overweight vehicles. The integration of the two companies' technologies is the first-of-its-kind solution and is already playing a crucial role in detecting overweight trucks in New York City while serving as a prototype for the rest of the nation.

09:10 EST CleanSpark announces agreement for up to 160,000 Bitmain S21 miners - CleanSpark announced the purchase of up to 160,000 Bitmain S21 miners, or the equivalent of 32 exahashes per second. Under the terms of the agreement, CleanSpark, one of the largest and most efficient publicly traded bitcoin mining companies in North America, has purchased 60,000 units with delivery expected April through June 2024. The agreement also includes a strategic call option to purchase an additional 100,000 machines at a fixed price of $16.00 per terahash until the end of the calendar year. If the full call option is exercised, CleanSpark's hashrate is expected to increase to approximately 50 EH/s, a 400% increase from its current hashrate of 10 EH/s, once all machines are deployed.

09:10 EST GeoVax Labs appoints Pipas as Executive Medical Director, Oncology - GeoVax Labs announced the appointment of J. Marc Pipas, M.D., to serve as the Company's Executive Medical Director, Oncology. Kelly McKee, M.D., MPH, GeoVax Chief Medical Officer, commented, "Dr. Pipas' addition to our team represents an important step forward in the strengthening of GeoVax's organizational and operational resources to support advancement of our principal oncology asset, Gedeptin(R), through clinical development and regulatory approval."

09:09 EST Borussia Dortmund CEO Hans-Joachim Watzke to depart - Hans-Joachim Watzke, CEO of Borussia Dortmund GmbH & Co. KGaA, has informed the Executive Committee of the Advisory Board of Borussia Dortmund Geschaftsfuhrungs-GmbH, chaired by President Dr. Reinhold Lunow, that he will not extend his managing director's employment contract, which currently runs until the end of 2025, and will step down from management in the fall of 2025.

09:07 EST Ivanhoe Electric provides update on activities at Santa Cruz Copper Project - Ivanhoe Electric Executive Chairman Robert Friedland and President and Chief Executive Officer Taylor Melvin are pleased to provide an update on ongoing infill and exploration drilling and technical work at the Santa Cruz Copper Project, located west of Casa Grande, Arizona. Mr. Friedland commented: "Our extensive exploration and development drilling programs at the Santa Cruz Copper Project have yielded very strong results and continue to uncover the full potential of the project. By incorporating sustainable technologies and renewable energy into the upcoming Prefeasibility Study and leveraging cutting-edge underground material handling methods, we are advancing studies at Santa Cruz for a modern, high-grade, underground copper mine with very low projected carbon dioxide-equivalent emissions. The fourth quarter of 2023 was an important time for the advancement of our Santa Cruz Copper Project in Arizona. We significantly increased our development drilling activity and received substantial assays from recent exploration drilling. In addition to raising our level of confidence in the Santa Cruz and East Ridge mineral resource estimates, recent infill drilling identified a large, high-grade oxide domain in the Santa Cruz deposit. This domain contains higher copper grades and is located in better quality ground conditions than previously modeled in our 2023 Initial Assessment. Our ongoing development drilling and test work will support the studies required for our Santa Cruz Prefeasibility Study, which we expect to complete before the end of Q2 2025. Beyond our development drilling at Santa Cruz and East Ridge, assays from recent step-out exploration at Texaco Ridge identified wide zones of primary sulfide mineralization that could provide future growth for our Santa Cruz Project. The combined success of our recent development and exploration drilling programs at Santa Cruz provides us with strong momentum as we enter 2024." 37 development drill holes totaling 25,176 meters have been drilled at the Santa Cruz and East Ridge Deposits since the release of the September 2023 Initial Assessment. The December 2022 Mineral Resource Estimate that formed the basis for the September 2023 Initial Assessment was modeled from 153,000 meters of drilling in 170 diamond drill holes. Since the effective date of the 2022 Mineral Resource Estimate, Ivanhoe Electric has completed an additional 76 drill holes, totaling 55,964 meters, with 25,176 meters drilled since the September 2023 Initial Assessment. Drilling activity at Santa Cruz ramped up in Q4 2023, with eight rigs drilling nearly 10,000 meters in November alone.

09:07 EST Kopin receives $20.5M contract for thermal weapon sight configuration - Kopin Corporation announced it received an approximate $20.5 million contract for a new weapon sight eyepiece configuration. Under the terms of the contract, Kopin is authorized to procure up to approximately $9 million of materials until the new weapon sight eyepiece configuration is fully qualified at which time the remaining contract balance will become effective, subject to standard government provisions. The new weapon sight eyepiece configuration is scheduled for deliveries in 2024 and 2025. The weapon sight eyepieces, which includes Kopin's proprietary high-brightness microdisplay and custom-designed Pancake optics, are critical components provided to a Department of Defense prime contractor that integrates the eyepiece into a sophisticated video "see through" augmented reality weapon system

09:05 EST Tryp Therapeutics receives HREC approval to commence Phase 1 TRP-8803 trial - Tryp Therapeutics announced a significant milestone in its clinical trial program for TRP-8803. The Company has received approval from the Human Research Ethics Committee in Australia to commence the groundbreaking Phase 1 clinical trial of TRP-8803 in healthy human volunteers. This study is designed to determine the optimal blood levels of psilocin needed to achieve the targeted psychedelic state. The trial, titled "A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of a Single Intravenous Infusion of TRP-8803 in Healthy Adult Participants," is set to be performed at the CMAX Phase 1 unit in Adelaide, Australia. This study is designed to provide a major advance in psychedelic medicine by aiming to optimize the doses and infusion rates of IV-administered psilocin to achieve targeted blood levels of psilocin. Uniquely, the study will also collect real-time electroencephalogram data from all nine human volunteers to monitor changes in EEG patterns associated with the psychedelic state, providing invaluable insights into the correlation between psilocin levels and the depth and duration of the psychedelic experience. This information is critical to advancement of TRP-8803 into future Phase 2 studies.

09:03 EST Apellis reports preliminary Q4 SYFOVRE revenue of $138M - Apellis Pharmaceuticals announced preliminary U.S. net product revenues of approximately $138 million for the fourth quarter for SYFOVRE for geographic atrophy secondary to age-related macular degeneration and for EMPAVELI for adults with paroxysmal nocturnal hemoglobinuria. "SYFOVRE is the market-leading treatment for GA, with approximately 160,000 doses distributed since launch. More patients than ever are benefiting from SYFOVRE, including the increasing treatment effects over time and flexible dosing, and we look forward to building on the momentum this year," said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer, Apellis. "Additionally, the high compliance observed with EMPAVELI speaks to the important impact of this medicine on patients' lives. In addition to advancing our pipeline, we believe the tremendous commercial progress made in the past year has positioned us for an even stronger 2024."

09:01 EST PharmAla Biotech receives U.S. Patent Prosecution Highway acceptance - PharmAla Biotech has received approval to move its PharmAla-1 molecule through the US Patent and Trademark Office Patent Prosecution Highway pathway based on the positive Patent Cooperation Treaty initial office action previously announced by PharmAla. The Patent Prosecution Highway speeds up the examination process for corresponding applications filed in participating intellectual property offices. Under PPH, participating patent offices have agreed that when an applicant receives a ruling from a first patent office indicating that at least one claim is allowable, the applicant may request fast track examination of corresponding claims. PharmAla-1 was first discovered through computational in-silico modelling exercises via PharmAla Biotech's partnership with the University of Windsor, for which PharmAla has also received a grant from the Ontario Centres for Innovation. Proof-of-concept testing for P-1 showed significant efficacy and pro-social effect at dosage levels far lower than MDMA, PharmAla's primary comparator molecule, as well as excellent safety pharmacology. P-1 is not considered a controlled substance anywhere in the world.

09:00 EST Nubia Brand International provides update on closing of business combination - Nubia Brand International announced that the conditions to closing the business combination between the Company and Honeycomb Battery Company, as described in the definitive proxy statement initially filed by Nubia with the SEC on November 8, 2023, have not yet been satisfied and the Business Combination has not closed. The parties are working together to expeditiously satisfy such closing conditions, including obtaining the approval of Nasdaq to list the post-combination company's common stock following the closing of the Business Combination. There can be no assurance that the Business Combination will be consummated within the time period required by Nubia's governing documents. If the Business Combination is not completed by March 15, 2024, Nubia may, among other things, cease all operations except for the purpose of winding up and, as promptly as reasonably possible, redeem shares of Nubia Class A common stock issued in Nubia's initial public offering at a per-share price payable in cash, which will be equal to the aggregate amount then on deposit in Nubia's trust account, including interest earned on the funds held in the trust account and not previously released to Nubia, divided by the number of Nubia Class A Shares then outstanding.

09:00 EST Butterfly Network announces FDA clearance of POCUS system, Butterfly iQ3 - Butterfly Network announced the FDA clearance of its next-generation handheld point-of-care ultrasound POCUS system, Butterfly iQ3. The new device is the company's third iteration of the world's first semiconductor-based single-probe, whole-body ultrasound system. Butterfly iQ3 features a brand-new ergonomic design and will deliver double the data processing speed for optimized image resolution, sensitivity and penetration, as well as faster 3D capabilities to power novel, automated image capture modes: iQ Slice and iQ Fan. "Butterfly iQ3 is the turning point for digital ultrasound. Butterfly started a revolution in ultrasound when we commercialized the world's first fully digital handheld ultrasound in 2018, and subsequently, iQ+ in 2020," said Joseph DeVivo, Butterfly Network's President, Chief Executive Officer and Chairman. "Over 145,000 customers have since realized the value of our chip-based ultrasound. With iQ3, the revolution takes full charge. Physicians across disciplines now rank our overall image quality at least equal to traditional piezoelectric-based handhelds, and our new digital capabilities are designed to make ultrasound more accessible and approachable than ever before." DeVivo continued, "I look forward to revealing more about iQ3's advanced imaging capabilities this week at the 42nd Annual J.P. Morgan Healthcare Conference. Stay tuned for more details about the product and its commercial launch in the United States this quarter."

09:00 EST ADiTx Therapeutics trading resumes

08:59 EST Moderna anounces upcoming pipeline milestones - Respiratory vaccines: Respiratory syncytial virus vaccine: Moderna has filed for regulatory approvals for its vaccine for the prevention of RSV-associated lower respiratory tract disease and acute respiratory disease in adults ages 60 years or older. The Company expects regulatory approvals beginning in the first half of 2024. Moderna will enter the RSV market with a strong competitive profile as the only pre-filled syringe product available at the time of launch, along with robust efficacy data, a well-established safety and tolerability profile, and widespread consumer awareness and demand established in 2023. Next-generation COVID-19 vaccine: Moderna's next-generation, refrigerator-stable COVID-19 vaccine is currently in its pivotal Phase 3 study. The Company anticipates data from the study in the first half of 2024. Seasonal flu vaccine: Moderna's seasonal flu vaccine demonstrated consistently acceptable safety and tolerability across three Phase 3 trials. In the most recent Phase 3 trial, mRNA-1010 met all immunogenicity endpoints, demonstrating higher titers compared to a currently licensed vaccine. mRNA-1010 has also shown higher or comparable titers compared to a currently licensed enhanced vaccine in a separate Phase 1/2 study. The Company is in discussions with regulators and intends to file in 2024. Seasonal flu + COVID vaccine: Moderna's Phase 3 trial of its combination vaccine against seasonal flu and COVID-19 is fully enrolled. The Company anticipates data from the study in 2024. Latent and other vaccines: Cytomegalovirus vaccine: The pivotal Phase 3 study of Moderna's CMV vaccine candidate is fully enrolled and accruing cases, evaluating its efficacy, safety and immunogenicity in the prevention of primary infection in women of childbearing age. The Company anticipates potential efficacy data from the study in 2024. Oncology therapeutics: Individualized Neoantigen Therapy: Moderna continues to demonstrate the potential clinical benefit of its INT program. In partnership with Merck, Phase 3 trials continue to enroll in resected high-risk melanoma and completely resected stage II, IIIA or IIIB non-small cell lung cancer. Moderna and Merck plan to rapidly expand their clinical studies to additional tumor types in 2024. The Company recently announced results of a three-year analysis of its Phase 2b study evaluating INT in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma. Compared to KEYTRUDA alone, this combination continued to show an improvement in recurrence-free survival, reducing the risk of recurrence or death by 49%, as well as in distant metastasis-free survival, reducing the risk of developing distant metastasis or death by 62%. Rare disease therapeutics: Propionic acidemia & methylmalonic acidemia: The Company expects to advance its PA and MMA programs into pivotal studies in 2024.

08:58 EST American Public Education names Karmela Gaffney as Chief Marketing Officer - American Public Education announced that Karmela Gaffney has joined the company as Senior Vice President and Chief Marketing Officer. A marketing professional with over 25 years of experience driving successful digital and integrated marketing strategies at Fortune 500 companies and higher education institutions, Gaffney will lead the APEI team to expand market strategy, shape brand identity, and attract and retain students on behalf of APEI's four educational institutions. Gaffney, APEI's Acting Chief Marketing Officer since July 2023, previously served as CMO at Academic Partnerships, where she led digital and organic marketing, operations, brand and product marketing, field sales, public relations, student experience, and research.

08:56 EST Trust Stamp provides update on low-code Orchestration Platform - Trust Stamp provides an update regarding the adoption of its low-code Orchestration Platform, which streamlines delivery and implementation of the Company's proven AI-Powered technologies. Since Trust Stamp's announcement in January 2023 that 22 customers were at various stages of implementing its Orchestration Layer, an additional 23 customers commenced or completed the process of implementing the Orchestration Layer bringing the year-end user base to 45 customers. Andrew Gowasack, President of Trust Stamp, commented, "We are pleased with the significant progress made in 2023 and we intend to build on that success over the coming year both by seeking additional growth in the user base and by supporting our existing customers with their integration and deployment. Although our primary marketing focus is on US financial institutions, the design of the Orchestration Layer allows for its implementation in many other sectors, both in the United States and overseas, and we are working actively on a number of domestic and international opportunities."

08:55 EST Oric provides initial Phase 1b data for ORIC-944, 2024 milestones - ORIC Pharmaceuticals announced initial data for its PRC2 inhibitor ORIC-944, operational highlights for 2023, and anticipated upcoming milestones. Initial Phase 1b Data for ORIC-944: As of December 10, 2023, the initial Phase 1b monotherapy data for ORIC-944, a potent and selective allosteric inhibitor of PRC2, in patients with metastatic prostate cancer demonstrated: Potential best-in-class drug properties, including clinical half-life consistent with preclinical prediction of greater than10 hours, which is superior to other PRC2 inhibitors and supports QD dosing; No signs of CYP autoinduction that is seen with first-generation PRC2 inhibitors; Robust target engagement with maximal decrease in H3K27me3 in monocytes from peripheral blood samples at doses as low as 200 mg QD, with low inter-patient variability; and Favorable safety with only grade 1 and 2 treatment-related adverse events at dose levels corresponding with strong target engagement. Emerging profile with superior drug properties support advancement into combination development in prostate cancer with AR inhibitor(s). 2023 Key Accomplishments: ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor: Presented initial data from the ongoing Phase 1b dose escalation trial. Presented preclinical data for ORIC-114 at ESMO Congress 2023. ORIC-944: a potent and selective allosteric inhibitor of PRC2: Presented preclinical data highlighting a comprehensive biomarker strategy for the ongoing Phase 1b trial in metastatic prostate cancer. Demonstrated via preclinical studies the potential for ORIC-944 to synergize with enzalutamide and other AR inhibitors in prostate cancer. ORIC-533: a highly potent, orally bioavailable small molecule inhibitor of CD73: Presented initial data from Phase 1b trial of ORIC-533 in patients with relapsed/refractory multiple myeloma at the 2023 ASH Annual Meeting. Expect to complete dose escalation for the Phase 1b trial of ORIC-533 in the first quarter of 2024, and company plans to pursue strategic partnership for combination studies. Discovery Pipeline: Presented preclinical data confirming the therapeutic potential of highly selective PLK4 inhibitors as a synthetic lethal therapy for TRIM37 amplified breast cancers at the 2023 AACR Annual Meeting. Advanced ORIC-613, a novel, highly selective PLK4 inhibitor, through IND enabling studies. Anticipated Program Milestones: ORIC-944 initiation of combination study with AR inhibitor: 1H 2024; ORIC-944 program update: mid-2024; ORIC-114 initiation of dose expansion in multiple cohorts: 1H 2024; ORIC-114 updated Phase 1b data: 1H 2025.

08:53 EST Newell Brands to reduce office roles by 7% in organizational realignment - Newell Brands announced an organizational realignment. Newell's organizational realignment is designed to further unlock operational efficiencies and cost savings, reduce complexity and free up funds for reinvestment. As part of the organizational realignment, the company is making several organizational design changes, which entail: standing up a cross-functional brand management organization, realigning business unit finance to fully support the new global brand management model, further simplifying and standardizing regional go-to-market organizations, and centralizing domestic retail sales teams, the digital technology team, business-aligned accounting personnel, the manufacturing quality team, and the human resources functions into the appropriate center-led teams to drive standardization, efficiency and scale with a One Newell approach. The company will also further optimize Newell's real estate footprint and pursue other cost reduction initiatives. These actions are expected to be substantially implemented by the end of 2024. Once organizational design changes are fully executed, the company expects to realize annualized pre-tax savings in the range of $65M to $90M, net of reinvestment, with $55M to $70M expected in 2024. Restructuring and related charges associated with these actions are estimated to be in the range of $75M to $90M and are expected to be substantially incurred by the end of 2024. The company plans to reduce its office roles by approximately 7%, with most of these actions expected to be complete by the end of 2024, subject to local law and consultation requirements.

08:51 EST Roadzen names Jean-Noel Gallardo as new CFO - Roadzen "announced the appointment of Jean-Noel Gallardo as its new Chief Financial Officer. Mr. Gallardo brings over two decades of experience in financial planning and analysis, treasury management, compliance, fundraising, and M&A, making him an integral addition to the Roadzen leadership team. Most recently, Mr. Gallardo was the Vice President of Finance at Aclaimant, Inc., an insurtech platform for safety and risk management."

08:51 EST Brera Holdings enters active Search for Italian Serie B football club target - The company states: "Brera Holdings is focused on multi club ownership, MCO, and expanding its global portfolio of professional sports clubs with an emphasis on football and its increased opportunities to earn tournament prizes, gain sponsorships, obtain transfer fees and provide other sports-related consulting services. Today Brera announced its launch of a proactive search for an Italian Serie B football club target designed to bring MCO of the highest tiers of professional sports ownership to mass investors through the Company's Nasdaq-listed shares."

08:49 EST Artelo Biosciences selects Worldwide Clinical Trials as CRO - Artelo Biosciences announced that it has selected Worldwide Clinical Trials to support the Company's planned Phase 1 trial with ART26.12, its Fatty Acid Binding Protein 5 inhibitor in development for the treatment of chemotherapy-induced peripheral neuropathy.

08:46 EST Ohmyhome, Webuy announce strategic collaboration - Ohmyhome (OMH) and Webuy Global (WBUY) announced a strategic collaboration to cross-sell both companies' respective products and services across Singapore. In a joint launch event held on January 8, 2024, Rhonda Wong, CEO and Co-founder of Ohmyhome, and Vincent Xue, CEO and Co-founder of Webuy, unveiled a series of collaborative partnership initiatives aimed at enhancing the customer experience and community engagement. Key initiatives include: Integration of Ohmyhome's Services into Webuy Communities: Ohmyhome's service offerings and property listings will be integrated into Webuy communities through its Group Leaders, where Group Leaders within each community would be responsible for a group of customers within their respective geographical location. This collaboration will facilitate off-market listings and provide exclusive benefits for Webuy's customers and Group Leaders, including Ohmyhome's brokerage and renovation services. Webuy's 'Group Buy' Services for Ohmyhome's Homeowners: Webuy will introduce its unique "group buy" service, offering a diverse range of daily products such as groceries and travel, to thousands of homeowners serviced by Ohmyhome. Offline Expansion Support: Ohmyhome, leveraging its expertise and network, will support Webuy and its Group Leaders in sourcing new storefronts.

08:45 EST LQR House Inc trading halted, news pending

08:41 EST Tian Ruixiang enter MOU to acquire licensed insurance broker in Hong Kong - TIAN RUIXIANG Holdings announced that TRX HongKong Investment, a wholly-owned subsidiary of the Company, has entered into a Memorandum of Understanding to acquire Peak Consulting Services Limited, a licensed insurance brokerage in Hong Kong. The proposed acquisition demonstrates the Company's strategic vision to expand into the Hong Kong insurance brokerage market. Pursuant to the MoU, the proposed acquisition is conditional upon, among other things, that TRX HongKong completes a due diligence review of the Target and is satisfied with its findings.

08:40 EST Vornado names Cushman & Wakefield as exclusive leasing agent of PENN 2 - Vornado Realty Trust (VNO) named Cushman & Wakefield (CWK) as the exclusive leasing agent of PENN 2, its 1.8 million square-foot PENN DISTRICT office tower. The Cushman & Wakefield agency team will be led by Bruce Mosler and Josh Kuriloff, who have recently been responsible for more than 7.7 million square feet in office leasing across Midtown Manhattan's burgeoning West Side. "We are excited to partner on PENN 2 with Cushman & Wakefield to continue our momentum in the PENN DISTRICT. This industry leading agency team has been most instrumental in the shifting of Midtown's center of gravity to Manhattan's Westside," said Glen Weiss, Executive Vice President, Office Leasing and Co-Head of Real Estate at Vornado Realty Trust. "The reimagined PENN 2 appeals directly to innovation-oriented companies seeking an ultra-premium, hospitality-infused office environment that offers a one-seat ride for workers throughout the Metropolitan region. We look forward to unveiling the new PENN 2 to the next generation of firms looking to join such stalwarts as Madison Square Garden, Meta, Morgan Stanley, Amazon, The Hartford, Cisco Systems and Samsung in the thriving PENN DISTRICT ecosystem."

08:39 EST Denny's reports preliminary Q4 domestic same-restaurant sales up 1.3% - Denny's reported selected preliminary and unaudited results for its fourth quarter and fiscal year ended December 27, 2023. Kelli Valade, Chief Executive Officer, stated, "We were pleased to deliver solid Denny's domestic system-wide same-restaurant sales in the fourth quarter, reflecting sequential improvement throughout the quarter, while also achieving results at the high-end of our previously guided range for the full year. Despite a persistently challenging operating environment, we enter 2024 with growing momentum towards our key strategies and the accelerated development of the Keke's brand." Denny's fourth quarter domestic system-wide same-restaurant sales were 1.3% compared to the equivalent fiscal period in 2022, including 1.5% at domestic franchised restaurants and (1.2)% at company restaurants. Denny's fiscal year domestic system-wide same-restaurant sales were 3.5% compared to the equivalent fiscal period in 2022, including 3.6% at domestic franchised restaurants and 2.7% at company restaurants. In 2023, the company opened 32 restaurants, including 11 international locations, and closed 57 restaurants, bringing the year-end total restaurant count to 1,631. In the fourth quarter, the company allocated $16.2M to share repurchases, resulting in $52.1M allocated to share repurchases for the full year. As of December 27, 2023, the company had approximately $100M remaining under its existing repurchase authorization. The company expects to release financial and operating results for its fourth quarter and fiscal year ended December 27, 2023, along with financial guidance for 2024, after the market closes on Tuesday, February 13, 2024.

08:39 EST Ascendis Pharma, Vector Pharma FZCO enter exclusive distribution agreement - Vector Pharma FZCO entered into an exclusive distribution agreement with Danish company Ascendis Pharma to commercialize both Skytrofa and Yorvipath in the Gulf Cooperation Council countries of Saudi Arabia, United Arab Emirates, Kuwait, Oman, Qatar and Bahrain. Under the terms of this exclusive distribution agreement, Vector will employ its sales and marketing expertise to distribute both Skytrofa and Yorvipath to patients in the GCC countries for the treatment of pediatric growth hormone deficiency in the case of Skytrofa, and adult hypoparathyroidism in the case of Yorvipath.

08:37 EST Olema Oncology nominates OP-3136 as development candidate - Olema Pharmaceuticals announced the selection of a development candidate for the Company's program targeting KAT6, an epigenetic target that is dysregulated in breast cancer and other cancers. The compound, named OP-3136, is an orally bioavailable, potent KAT6A/B-selective inhibitor developed by Olema in collaboration with Aurigene Oncology. Olema presented data regarding the discovery and pre-clinical development of its KAT6 program in a poster session at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, Massachusetts. OP-3136 is orally bioavailable in multiple non-clinical species with desirable pharmacokinetics and has demonstrated highly selective and potent activity against KAT6A and KAT6B versus other KAT family members. In KAT6-amplified and overexpressing estrogen receptor-positive breast cancer cell lines, OP-3136 strongly inhibited cell proliferation whereas KAT6-low cell lines were insensitive to the compounds. In a non-clinical xenograft model, OP-3136 caused dose-dependent tumor growth inhibition and tumor regression comparable to or better than a positive-control patented KAT6 inhibitor and demonstrated synergy in combination with CDK4/6 inhibitors or palazestrant. Olema is initiating non-clinical Investigational New Drug enabling studies in order to support a potential IND submission to the U.S. Food and Drug Administration for OP-3136 by the end of 2024.

08:36 EST Infinera's optical transport solution deployed by Xarxa Oberta de Catalunya - Infinera announced that Xarxa Oberta de Catalunya deployed Infinera's XTM Series to meet the growing broadband demands of government networks across the Catalonia region in Spain. With Infinera's XTM packet-optical solution, Xarxa Oberta can provide government networks up to 400 GbE services on its fiber optic network. Xarxa Oberta also tested Infinera's ICE6 solution on the GX Series Compact Modular Platform, validating its ability to run optical signals up to 800G on its network to allow for scaling in the future. Infinera's XTM Series equips Xarxa Oberta with a range of innovative packet optical transport solutions to deliver an architecture optimized for the needs of the region. The XTM Series solution enhances Xarxa Oberta's network, enabling it to extend flexible, reliable high-capacity connectivity with low power consumption to government networks.

08:34 EST SunCar Technology signs vehicle service contract with China Construction Bank - SunCar Technology Group announced a two-year exclusive vehicle service contract with the Fujian Branch of China Construction Bank, one of the most prestigious financial institutions in China. SunCar expects to derive cumulative revenue from the contract valued at approximately $3.5M. Following a competitive bidding process, SunCar was selected as the exclusive provider of vehicle services for the customers of China Construction Bank's Fujian Branch. This win underscores SunCar's trusted reputation in the industry and position as the leading choice for after-sales car services in China. SunCar's extensive network of 460 car wash locations across Fujian allows the Company to offer an unparalleled car wash experience to tens of thousands of China Construction Bank customers, ensuring their vehicles are cared for with the utmost professionalism.

08:34 EST ProSomnus comments on insurance coverage policy update - ProSomnus welcomes the adoption of UnitedHealthcare's updated medical policy for Obstructive and Central Sleep Apnea, effective March 1, 2024. The updated policy will establish oral appliance therapy, such as ProSomnus's Precision OAT devices, as prerequisite therapy for Implantable Hypoglossal Nerve Stimulation in adult patients with moderate to severe OSA. Specifically, the policy states, "Failure of adequate trial of Oral Appliance therapy," as the new medical policy of UHC. "I am pleased to see this policy update acknowledging the role of oral appliances in the continuum of care for Obstructive Sleep Apnea," commented Edward T. Sall, MD, DDS, MBA. "Recent research has demonstrated that modern, precision oral appliances are effective and safe. It is good medical practice to exhaust the available, non-invasive, reversible treatment options before moving to surgical options."

08:31 EST Liquidia files response and counterclaims to United Therapeutics lawsuit - Liquidia (LQDA) "announced it filed its answer, affirmative defenses and a partial motion to dismiss in response to the amended patent infringement complaint filed by United Therapeutics Corporation (UTHR) on November 30, 2023, under the Drug Price Competition and Patent Term Restoration Act in the U.S. District Court for the District of Delaware (District Court) that alleges the infringement of U.S. Patent No. 10,716,793 (the '793 patent) and U.S. Patent No. 11,826,327 (the '327 patent) in association with Liquidia's New Drug Application for YUTREPIA (treprostinil) inhalation powder. Simultaneously, Liquidia filed counterclaims against UTHR seeking a declaration that all asserted claims of the '327 patent are not infringed, are invalid and are unenforceable. Furthermore, the counterclaims summarize certain publications, references and information that UTHR failed to submit to the United States Patent and Trademark Office during the prosecution of the '327 patent." CEO Dr. Roger Jeffs said: "United Therapeutics seeks to interfere with our launch of YUTREPIA in PH-ILD by relitigating the same '793 patent that was previously found to be invalid and asserting a new patent that was procured without submitting highly material prior art references and important additional information to the USPTO. We will continue to aggressively defend ourselves and the ability of patients suffering from PAH and PH-ILD to have a choice of products to treat their rare and deadly disease."

08:29 EST Xenon Pharmaceuticals outlines milestone opportunities for 2024 - Xenon Pharmaceuticals outlined progress within its pipeline programs and key milestones for 2024. Pipeline Programs and Anticipated Milestones: XEN1101 is a novel, potent Kv7 potassium channel opener being developed for the treatment of epilepsy, major depressive disorder, and potentially other neurological disorders. Xenon anticipates that patient enrollment in X-TOLE2 will be completed in the second half of 2024. XEN1101 for Epilepsy: Xenon's Phase 3 X-ACKT clinical trial is intended to support potential regulatory submissions in an additional epilepsy indication of primary generalized tonic-clonic seizures, or PGTCS. This multicenter, randomized, double-blind, placebo-controlled study is evaluating the clinical efficacy, safety, and tolerability of 25 mg of XEN1101 administered with food as adjunctive treatment in approximately 160 patients with PGTCS. XEN1101 for Epilepsy: Upon completion of the double-blind period in X-TOLE2, X-TOLE3, or X-ACKT, eligible patients may enter an open-label extension, or OLE, study for up to three years. In addition, the ongoing X-TOLE Phase 2b OLE continues to generate important long-term data for XEN1101. XEN1101 for Major Depressive Disorder: Xenon is actively assessing various clinical and regulatory pathways to support late-stage clinical development of XEN1101 in MDD and expects to initiate the Phase 3 clinical program in 2024. Xenon is also evaluating other potential indications for the future development of XEN1101. In addition, Xenon is collaborating with the Icahn School of Medicine at Mount Sinai to support an ongoing investigator-sponsored Phase 2 proof-of-concept, randomized, parallel-arm, placebo-controlled multi-site study of XEN1101 for the treatment of MDD in approximately 60 subjects. Partnered Programs: Xenon has an ongoing collaboration with Neurocrine Biosciences to develop treatments for epilepsy. Pre-Clinical Programs: Xenon continues to leverage its extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. The near-term focus is on development candidates targeting Kv7, Nav1.1 and Nav1.7 where Xenon expects multiple candidates will enter IND-enabling studies in 2024 and 2025. Additional updates will be provided as these pre-clinical drug candidates advance through IND-enabling studies and into clinical development.

08:29 EST Marker Therapeutics announces clinical program updates, pipeline prioritization - The company states: "Marker Therapeutics announced a restructuring of its clinical programs and a strategic prioritization of its multi-tumor associated antigen (multiTAA)-specific T cell product pipeline. In addition, the Company reported a clinical update on the Phase 2 ARTEMIS study investigating MT-401, a multiTAA-specific T cell product, for the treatment of patients with acute myeloid leukemia. Following the non-dilutive transaction with Cell Ready, Marker has made significant progress on clinical and corporate restructuring with the objective of accelerating the commercial development of our unique multiTAA technology. The Company today announced the prioritization of MT-601 in chimeric antigen receptor (CAR) relapse patients with lymphoma. This strategic decision was made based on 1) the Company's promising non-clinical and clinical data using the multiTAA technology in lymphoma, and 2) the lack of an approved treatment for patients who experience relapse after treatment with CD19 CAR T, which is a clear unmet medical need and provides an opportunity for accelerated product development. Today, Marker is providing a clinical update on the Phase 2 ARTEMIS clinical study, and the direction it will pursue. This multicenter study is evaluating the safety and efficacy of MT-401 in patients with AML after allogeneic hematopoietic stem cell transplantation. A total of 8 patients with MRD+ AML after HSCT were enrolled and treated with MT-401. None of the 8 treated patients experienced a drug related adverse event. Of the 8 treated patients, 4 experienced a clinical benefit, with 3 showing a conversion to MRD-negative, and one patient showing a partial response with a logarithmic reduction of MRD levels by PCR. One patient has not yet had the first assessment post treatment. Of the 8 treated patients in the study, only 1 patient had documented disease progression and was taken to a second transplant. The other 3 patients were taken off the study for reasons unrelated to the clinical outcome. Obtaining timely consent and re-accessing HSCT donors for apheresis for the manufacture of MT-401 caused delayed patient accrual and patient eligibility issues. Consequently, the rapid progression of disease contributed to some patients to withdraw from the study prior to administration of study product. Therefore, to streamline resources and to reduce time to treatment, Marker intends to focus on a ready for use product from commercially available leukapheresis material and will discontinue the patient-specific part of the AML program." CEO Juan Vera stated: "The data demonstrate the safety of MT-401 and provide evidence that MT-401 could benefit patients with MRD+ AML. Decreasing the time to treatment is critical when it comes to the treatment of patients that suffer from rapidly progressing cancers, such as patients with MRD in AML, which typically advances rapidly into frank relapse with poor outcomes. We believe using commercial leukapheresis material from healthy donors can bypass the bottleneck associated with donor identification and facilitate large-scale manufacturing. This approach is expected to not only reduce manufacturing costs, but also expedite time to treatment to as little as 72 hours. We are currently working to initiate the clinical study and anticipate that the first patient with AML will be treated with MT-401 manufactured from healthy donors in the second half of 2024."

08:28 EST Mesa Labs appoints Mark Capone to board of directors - Mesa Laboratories announced the appointment of Mark Capone to its Board of Directors, effective January 5, 2024. Following Mr. Capone's election, the Mesa Board will be comprised of 7 directors, the majority of whom are independent. The Board is committed to ongoing director refreshment and continues to consider new, qualified independent directors. Capone most recently served as CEO and President of Myriad Genetics for five years

08:26 EST GE HealthCare to acquire MIM Software in accretive deal, no terms - Financial details of the transaction have not been disclosed publicly. GE HealthCare intends to fund this transaction with cash on hand. The Company expects this transaction to be neutral to Adjusted EBITi in year one and accretive thereafter.

08:25 EST ADiTx Therapeutics trading halted, news pending

08:24 EST Wave Life Sciences: Selection of clinical candidate in obesity planned for Q3 - The company says it has identified potent and highly specific INHBE siRNA leads and now expects to select an INHBE clinical candidate in the third quarter of 2024, ahead of expectation. This would enable clinical trial application submission in 2025, Wave said in a statement. Wave also said it plans to deliver proof-of-mechanism data in individuals with AATD in 2024 for WVE-006. Dosing is underway in a potentially registrational FORWARD-53 trial evaluating WVE-N531 in DMD; 24-week data, including dystrophin from muscle biopsies, expected in Q3, the company added. Also, WVE-003 30 mg Q8W multi-dose data with extended follow-up is on track for 2Q 2024; most advanced program designed to lower mutant HTT while also sparing wild-type HTT, Wave said.

08:24 EST Denali Therapeutics announces key anticipated 2024 milestones, priorities - Denali Therapeutics announced program progress and expected milestones for 2024. Tividenofusp alfa: MPS II: 2024 expected progress and milestones: Complete enrollment of global Phase 2/3 COMPASS study in MPS II; Presentation of additional interim Phase 1/2 data at WORLDSymposium and at the Society for the Study of Inborn Errors of Metabolism Annual Symposium. DNL343: ALS: 2024 expected progress and milestones: Complete enrollment of participants in Regimen G in Phase 2/3 HEALEY ALS Platform Trial. SAR443820/DNL788: ALS, MS: 2024 expected progress and milestones: Sanofi to announce topline results from the Phase 2 HIMALAYA study in ALS in the first half of 2024; Continue K2 Phase 2 study in MS. BIIB122/DNL151: Parkinson's disease: 2024 expected progress and milestones: Continue Phase 2b LUMA study in early-stage Parkinson's disease. Eclitasertib UC: 2024 expected progress and milestones: Continue Phase 2 UC study. TAK-594/DNL593: Frontotemporal Dementia-Granulin: 2024 expected progress and milestones: Continue Part B of the Phase 1/2 study in FTD-GRN. DNL126: MPS IIIA: 2024 expected progress and milestones:Biomarker proof of concept and safety data from the Phase 1/2 study by the end of 2024

08:23 EST Corcept Therapeutics announces $200M stock buyback - The company states: "Our Board of Directors has approved a program authorizing the repurchase of up to $200 million of the company's common stock. Purchases under this program may be made in the open market, in privately negotiated transactions or otherwise. The timing and amount of any repurchases will be determined based on market conditions, our stock price and other factors. The program does not require the company to repurchase any specific number of shares of its common stock and may be modified, suspended or discontinued at any time without notice."

08:21 EST American Eagle raises Q4 operating profit view to $130M from $105M-$115M - American Eagle announced that fourth quarter-to-date revenue, through Saturday, December 30, 2023, is up approximately 8%, with American Eagle tracking up high single digits and Aerie up in the low teens. The company said, "The company is raising its fourth quarter outlook for revenue to be up low double digits, including a four point positive contribution from the 53rd week, as previously discussed. Operating profit is now expected to be approximately $130 million, up from previous guidance of $105 to $115 million. This guidance excludes potential asset impairment and restructuring charges. The improved outlook is a result of record holiday sales and strong merchandise margins."

08:19 EST Affimed announces strategic restructuring, reducing headcount by 50% - Affimed "announces a restructuring initiative aimed at transforming the Company into a focused clinical organization, positioned to successfully advance its clinical programs to key value inflection points. Key highlights of the restructuring plan include: Focus on Clinical Programs: Affimed will direct all resources towards advancing the development of its clinical programs; Workforce reduction - Affimed will reduce its workforce by up to 50% by dissolving its research and preclinical development departments, aligned with the Company's narrowed strategic priorities; Prolonged Cash Runway - The restructuring plan announced today will extend Affimed's cash runway into H2 of 2025."

08:19 EST HP Inc. announces innovations across OMEN, HyperX brands - HP unveiled its gaming portfolio with innovations across its OMEN and HyperX brands. New laptops, accessories, and software are all designed to work together to create a seamless gaming ecosystem so gamers can focus on what they do best - play. "Computing continues to become more personal, and this is especially true in the gaming community," said Josephine Tan, Senior Vice President & Division President of Personal Systems Gaming Solutions, HP Inc. "Whether it is your gaming laptop, monitor, or accessory, HP has developed a customizable and personalized solution that can be tailored to your need."

08:18 EST Gentex enters partnership with Solace - Gentex Corporation announced a partnership agreement with Solace Power, an innovative wireless power transfer technology company. The goal of the collaboration is to further develop, manufacture, and commercialize Solace's unique wireless power systems within a wide variety of industries. The collaboration brings with it a strategic investment by Gentex in Solace Power. Solace Power specializes in making wireless power and data transfer practical for applications across a broad spectrum of industries, including automotive, telecommunications, smart home, aerospace, and healthcare. The company's proprietary technology, supported by 27 patents and hundreds of trade secrets, can continuously deliver up to 3 kilowatts of power at distances up to 375mm through various mediums including air, glass, wood, and concrete. With its vast range of capabilities, Solace's technology unlocks significant improvements in manufacturability, power transfer reliability, and spatial freedom. While Solace already maintains a diverse customer base, the companies hope to leverage Gentex's manufacturing and product development capabilities to help Solace achieve market scale. Gentex believes Solace's technology not only has immediate applications in its current product portfolio, but also stands to play an important role in the company's continued expansion into new markets.

08:17 EST Harmony Biosciences sees Q4, FY23 net product revenue growth of over 30% - The company also provided 2024 net product revenue guidance of $700 to $720 million and outlined key priorities in advance of its presentation at the 42nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2024 at 5:15 p.m. PT / 8:15 p.m. ET. "In 2023, Harmony advanced our clinical development programs and diversified our portfolio while achieving net revenue of approximately $582 million," said Jeffrey M. Dayno, M.D., Harmony President and CEO. "We enter 2024 poised to generate up to $720 million in net revenue and are well on our way toward a one billion dollar plus opportunity for WAKIX in adult narcolepsy alone. Leveraging our strong cash position, as well as our expertise in clinical development and commercial execution, we will continue to advance our growth strategy by adding new products to build out a robust pipeline." Preliminary, unaudited net product revenue for the quarter ended December 31, 2023, was approximately $168 million, compared to $128.3 million for the same period in 2022, representing ~31% growth. Preliminary, unaudited net product revenue for the full year ended December 31, 2023, was approximately $582 million, compared to $437.9 million for the same period in 2022, representing ~33% growth. The average number of patients on WAKIX increased by approximately 350 sequentially to approximately 6,150 for the quarter ended December 31, 2023.

08:16 EST Aclarion, ATEC execute strategic partnership agreement - Aclarion has executed a strategic partnership agreement solidifying the previously signed non-binding Letter of Intent with Alphatec Spine, Inc., the wholly owned operating subsidiary of Alphatec Holdings. Uniting the unique structural information powered by ATEC's AlphaInformatiX platform with the innovative biomarker data that enables Aclarion's Nociscan solution to help identify potentially painful discs will provide surgeons with unprecedented data on one platform. That platform will be designed to improve clinical outcomes, while reducing overall procedural costs for patients with chronic low back pain. The agreement memorializes a multi-step strategic partnership in which ATEC and Aclarion have committed to work together to identify key opinion leader surgeons to evaluate the Nociscan technology. Feedback from the surgeons will inform clinical evaluations designed to assess the utility of Nociscan in conjunction with EOS imaging, the foundation of ATEC's AlphaInformatiX platform. As positive synergies emerge, ATEC and Aclarion intend to co-market Nociscan in targeted markets. In exchange for select access to ATEC's surgeon network for the evaluation and advancement of Nociscan, Aclarion has agreed to provide ATEC with certain exclusive distribution rights to include Nociscan as part of an integrated procedural solution.

08:15 EST OrthoPediatrics announces acquisition of Boston Orthotics & Prosthetics - OrthoPediatrics announced that it has acquired Boston Orthotics & Prosthetics, a leader in pediatric orthotic management for over 50 years. Additionally, in advance of the acquisition, the Company closed a debt financing with MidCap Financial which provides up to $80 million of capital, through the combination of a term loan and revolving loan, replacing its prior unused $50 million line of credit. Partnering with world class medical facilities, including Boston Children's Hospital, Children's Hospital of Philadelphia, Nationwide Children's Hospital in Columbus, Ohio, and Phoenix Children's Hospital, Boston O&P maintains 26 patient care clinics across the U.S. Boston O&P's recent annual historical revenue is approximately $25 million. Transaction Details and Debt Financing: Under terms of the transaction, signed and closed on January 5, 2024, OrthoPediatrics has acquired Boston O&P for an upfront cash payment of $22 million. Post closing, OrthoPediatrics cash and restricted cash balance is approximately $60 million. In advance of the acquisition, OrthoPediatrics entered into a new credit agreement with MidCap Financial, consisting of term loan and revolving loan. The term loan provides up to $30 million of capital and the revolving loan provides up to an additional $50 million, for a total availability of $80 million. The credit agreement replaces the previously unused $50 million line of credit with Squadron Capital. In advance of the acquisition, OrthoPediatrics drew an initial $10 million from the term loan.

08:14 EST Fate Therapeutics announces initiation of Phase 1 trial of FT825/ONO-8250 - Fate Therapeutics announced the initiation of enrollment for its Phase 1 clinical trial of FT825 / ONO-8250, a multiplexed-engineered, chimeric antigen receptor T-cell product candidate targeting human epidermal growth factor receptor 2. The iPSC-derived CAR T-cell product candidate incorporates a novel HER2-targeted antigen binding domain and is designed to overcome unique challenges in treating solid tumors. The Phase 1 study of FT825 / ONO-8250 is being conducted under a strategic collaboration with Ono Pharmaceutical Co. Designed using the Company's iPSC Product Platform, FT825 / ONO-8250 incorporates seven novel synthetic controls of cell function including a CXCR2 receptor to promote cell trafficking, a chimeric TGFbeta receptor to redirect immunosuppressive signals in the tumor microenvironment, and a high-affinity, non-cleavable CD16a receptor to enable antibody-dependent cellular cytotoxicity. Preclinical data of FT825 / ONO-8250 presented at the 2023 Society for Immunotherapy of Cancer Annual Meeting demonstrated that the profile of the novel HER2-targeted antigen binding domain is unique and differentiated from that of trastuzumab, exhibiting similar potency with greater specificity for cancer cells expressing HER2. The Phase 1 study is designed to investigate a single dose of FT825 / ONO-8250 as monotherapy and in combination with monoclonal antibody therapy in previously-treated patients with advanced solid tumors. The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability, and pharmacokinetics as well as anti-tumor activity by overall response rate, duration of response and disease control rate. Under the terms of its Collaboration and Option Agreement with Ono, Fate will jointly develop and commercialize FT825 / ONO-8250 with Ono in the U.S. and Europe, and Ono maintains exclusive development and commercialization rights for FT825 / ONO-8250 in the rest of the world. Fate is eligible to receive clinical, regulatory and commercial milestone payments as well as tiered royalties on net sales outside of the United States and Europe by Ono. The parties are currently conducting preclinical development of an additional solid tumor program targeting an undisclosed tumor-associated antigen.

08:13 EST NewAmsterdam Pharma appoints William Lewis as chair of board - NewAmsterdam Pharma Company announced the appointment of William H. Lewis, J.D., M.B.A., as Chair of its Board of Directors. Mr. Lewis has served as CEO of Insmed Incorporated, a global commercial-stage biopharmaceutical company, since 2012, and as Chair of Insmed's Board of Directors since 2018. Mr. Lewis succeeds Sander Slootweg, Managing Partner at Forbion, who has served as Chairman of NewAmsterdam's Board of Directors since inception.

08:12 EST Stryker announces 2023 sales surpassed $20B - Stryker announced that it surpassed $20 billion in annual sales for the first time in its history during the month of December, 2023. "We are excited to surpass this major milestone and to share with our employees as we have our kick-off meetings for 2024," said Kevin Lobo, Chair and Chief Executive Officer. "This means that we are positively impacting more customers and patients than ever." Stryker will disclose additional information regarding its 2023 financial results during its Q4 and Full Year Earnings Call, scheduled for January 30, 2024.

08:11 EST EDAP TMS announces preliminary Q4 Focal One system sales, placements - EDAP TMS announced preliminary Focal One placement results for the fourth quarter of calendar year 2023. The Company experienced robust demand for its Focal One robotic HIFU technology, placing twelve Focal One systems, inclusive of ten capital sales. Additionally, it was a record quarter for sales of ExactVu Micro-Ultrasound systems used for prostate biopsy. The breadth of these new Focal One and ExactVu placements continues to be strong, with growing interest amongst both academic medical centers and community hospitals. "Our Focal One commercial team continues to gain significant momentum as reflected by our record-setting number of capital sales as well as overall system placements in the fourth quarter of 2023," said Ryan Rhodes, Chief Executive Officer of EDAP. "Utilizing our state-of-the-art robotic technology platform, a growing number of urologists can now offer their patients a non-invasive, tissue-sparing treatment option that provides excellent oncologic outcomes with the opportunity for preserving patient quality of life. Looking ahead, we believe Focal One is quickly becoming a necessary solution in the management of prostate cancer, and our team is leading the effort to help urology practices establish world-class treatment programs with our Focal One platform."

08:10 EST AbbVie reports 'positive' results from Phase 2 trial of lutikizumab - AbbVie announced Phase 2 results showing adults with moderate to severe hidradenitis suppurativa who had previously failed anti-TNF therapy who received lutikizumab 300 mg every other week or 300 mg weekly achieved higher response rates than placebo in the primary endpoint of achieving HS Clinical Response at week 16. Based on these data, AbbVie will advance its clinical program of lutikizumab in HS to Phase 3. Lutikizumab is AbbVie's investigational, dual-variable-domain interleukin 1alpha/1beta antagonist. Studies have shown IL 1alpha and 1beta are elevated in HS lesions.

08:09 EST Ceridian says retailers choose Dayforce to optimize workforce planning - Ceridian announced its upcoming retail product innovations, which highlight the company's growing momentum in the sector. As the only solution that offers workforce management and global payroll capabilities on a single platform, Dayforce - Ceridian's industry-leading cloud software - helps retailers and the hospitality industry empower and retain frontline workers, increase operational agility when making staffing decisions, and enhance the employee experience. Ceridian helps more than 1,280 retailers around the world optimize their workforce and improve employee engagement, attraction, and retention, including American Dream, Buehler's Fresh Foods, Costa Coffee, Sobeys, and SPARC Group LLC, which owns and operates leading retail brands including but not limited to Aeropostale, Brooks Brothers, Forever 21, and Reebok.

08:08 EST Pasithea Therapeutics announces invention of crystalline form of PAS-004 - Pasithea Therapeutics announced the invention of a crystalline form of PAS-004 which is captured in polymorph and stereoisomer patent filings that when issued we believe will extend patent protection to at least 2045.

08:06 EST Orchestra BioMed announces initiation of BACKBEAT study of AVIM therapy - Orchestra BioMed Holdings (OBIO) announced the first patient was randomized in the BACKBEAT pivotal study in late December 2023. The BACKBEAT pivotal study will evaluate the efficacy and safety of atrioventricular interval modulation therapy, for the treatment of pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications. AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker, designed to immediately, substantially and persistently reduce blood pressure. Orchestra BioMed and Medtronic (MDT) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022. "We are thrilled to announce the initiation of the BACKBEAT pivotal study. This is an essential milestone as we evaluate how this therapy may benefit pacemaker patients who confront the mortality and morbidity risks of elevated blood pressure," commented David Hochman, chairman, chief executive officer and founder of Orchestra BioMed. "We have activated multiple clinical sites and are screening patients in the U.S. and Europe. We are grateful to the clinical sites, our team and Medtronic for their dedication to finalizing all the study initiation deliverables. Most importantly, we are thankful to the patients who will participate in this landmark study."

08:05 EST Abeona Therapeutics announces $50M credit facility - Abeona Therapeutics entered into a $50 million credit facility with the Avenue Venture Opportunities Fund, L.P. The credit agreement, which has a term of three and a half years, includes a first tranche of $20 million at closing, a second tranche of $10 million of committed capital, and an additional accordion option to upsize the credit facility by an additional $20 million upon satisfaction of certain terms and conditions. Proceeds from the facility are intended to support the Company's ongoing preparations for launch and commercialization in anticipation of a potential approval for marketing in the U.S. by the Food and Drug Administration of pz-cel , Abeona's investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic epidermolysis bullosa and for general corporate purposes. The FDA has accepted and granted Priority Review with a PDUFA target action date of May 25, 2024 for the Biologics License Application for pz-cel. A.G.P./Alliance Global Partners served as financial advisor and sole lead arranger to the Company on this transaction.

08:03 EST Fortrea Holdings previews J.P. Morgan Healthcare conference updates - Fortrea previewed key updates that Tom Pike, chairman and chief executive officer, and Jill McConnell, chief financial officer, plan to present at the 42nd Annual J.P. Morgan Healthcare Conference. Fortrea continues to make strong progress in establishing its fit-for-purpose infrastructure, exiting approximately 40 percent of its Transition Services Agreements with its former parent company by the end of 2023. In addition, the Company has selected two leading technology providers to support the exit of its technology-related TSAs. Fortrea recently hired a recognized industry expert and leader in artificial intelligence to lead Fortrea's efforts in AI and machine learning. Fortrea also made progress in winning new business, delivering a book-to-bill ratio that exceeded 1.2x for the fourth quarter of 2023 and achieving its intended target of more than 1.2x for its first six months as an independent organization.

08:02 EST Emerita Resources provides summary of 2023, 2024 milestones - Emerita Resources provides the following summary of the Company's progress in 2023 and lay out priorities for 2024. 2023 was a watershed year in the advancement of Emerita's wholly-owned Iberia Belt West Project and momentum is expected to continue into 2024. David Gower, P.Geo., CEO of Emerita remarks, "In 2023 our team delivered on several major milestones for the Company and for IBW. Our team made excellent progress at IBW as we advance towards a potential production decision. In May, the Company released the maiden independent NI 43-101 compliant mineral resource estimate. In September, the Company announced it had filed an application for an exploitation licence for IBW to the Delegacion Territorial de Energia y Minas in Huelva province, Junta de Andalucia. In December, the Company completed the submission of the required application documentation for the exploitation license. Looking forward, 2024 will see the Company continue efforts to expand the IBW resource and the first drill campaign at Nuevo Tintillo will be completed. In parallel with ongoing exploration efforts, the Company will continue de-risking IBW with metallurgical testing and engineering and economic studies targeted for completion in H1 2024. The Company is in a solid financial position to continue this work. In February, Ian Parkinson joined the Company as EVP of Corporate Development and Capital Markets. Ian brings technical as well as Capital Markets expertise after 15 years as a senior metals analyst as well as working in geological and commercial functions with Falconbridge. Ian has been a great addition to the team."

08:00 EST First Watch Restaurant to acquire 21 franchise restaurants in North Carolina - First Watch Restaurant Group announced it has agreed to acquire 21 of its franchise-owned restaurants and corresponding development rights in North Carolina for an aggregate purchase price of $75 million on a cash-free, debt-free basis, subject to certain customary adjustments. "Our acquisition of franchise-operated restaurants is an important part of our long-term growth and value creation strategy, and this represents our most significant transaction to date," said Chris Tomasso, First Watch CEO & President. "We expect these 21 restaurants in one of our key markets will generate average unit volumes and restaurant level operating profit margins in line with our Company-owned restaurants and provide us with additional territories in which to grow organically for years to come. We look forward to welcoming the teams from these restaurants, who have served their communities in North Carolina for nearly 10 years, to our You First culture."

07:59 EST Mereo BioPharma provides update on pipeline progress, corporate developments - Mereo BioPharma Group (MREO) provided an update on its pipeline programs as well as an update on recent corporate developments. Recent Pipeline Progress: Setrusumab: Enrollment in the Phase 3 portion of the Global Phase 2/3 Orbit study led by Mereo's partner, Ultragenyx Pharmaceutical, was initiated in mid-2023 and the study is expected to be fully enrolled around the end of the first quarter of 2024. Recent data reported in October 2023, from the 24 patients enrolled in the Phase 2 portion of the Orbit study with at least 6 months of treatment, showed that treatment with setrusumab reduced the annualized fracture rate by 67%. If approved by the U.S. Food and Drug Administration and the European Medicines Agency, setrusumab would be the first FDA and EMA-approved treatment for Osteogenesis Imperfecta. Alvelestat: The Company has continued its interactions with the Division of Pulmonology, Allergy and Critical Care and the Division of Clinical Outcome Assessment of the FDA regarding the use of a Patient Reported Outcome instrument as a potential primary endpoint in its planned Phase 3 study of alvelestat for the treatment of Alpha-1 Antitrypsin Deficiency-associated Lung Disease. Data from both the ATALANTa and ASTRAEUS studies support the use of the SGRQ Total Score as the primary endpoint in the proposed Phase 3 study based on benefits observed in patients with the severe Pi*ZZ phenotype, including those who are in the early stages of the lung disease. In some countries, these patients are currently not eligible for, or not treated with, augmentation therapy. Following additional FDA interactions in the fourth quarter of 2023, subsequent to the DCOA meeting, the Company has aligned on a Phase 3 study design using SGRQ Total Score as the primary endpoint with a functional assessment as a key secondary endpoint which, if the study is successful, is expected to support submissions for full regulatory approval in the U.S. Inclusion of patients with earlier and later stage lung disease progression in the planned registrational study could increase the addressable patient population for alvelestat. The Company remains engaged with multiple potential partners for the development and potential commercialization of alvelestat and expects to provide further details on these efforts in 2024. Leflutrozole: The Company recently entered into an exclusive global license agreement with ReproNovo SA for the development and commercialization of leflutrozole, a non-steroidal aromatase inhibitor. Under the terms of the License Agreement, ReproNovo, a reproductive medicine company, is responsible for all future development and commercialization of leflutrozole.

07:59 EST Monte Rosa Therapeutics provides updates, milestones for 2024 - The company states: "Monte Rosa Therapeutics outlined anticipated 2024 milestones ahead of its participation in the 42nd Annual J.P. Morgan Healthcare Conference. The company's presentation, taking place on Wednesday, January 10, 2024, at 3:00 p.m. PT, will focus on strategic priorities for 2024, including anticipated progress with the ongoing Phase 1/2 clinical trial of MRT-2359 in MYC-driven solid tumors as well as future development plans for MRT-2359 and MRT-6160, its VAV1-directed MGD for autoimmune diseases." The company's 2024 Corporate Updates and Key Anticipated Milestones include: "Monte Rosa announced today that it has received U.S. Food & Drug Administration Fast Track Designation for MRT-2359 for the treatment of patients with previously treated, metastatic small cell lung cancer (SCLC) with L-MYC or N-MYC expression; Monte Rosa expects to announce the RP2D for the MRT-2359 Phase 1/2 clinical trial in MYC-driven solid tumors in Q2 2024. Enrollment is ongoing in backfill cohorts at clinically active doses using a 5 days on drug, 9 days off drug schedule. The Company has simultaneously started dose escalation of higher dose density cohorts using a 21 days on, 7 days off schedule; The Company expects to submit an IND for MRT-6160, a VAV1-targeted MGD, in the first half of 2024 and to initiate a Phase 1 single ascending dose / multiple ascending dose study in healthy volunteers in mid-2024; The Company expects to nominate a development candidate for the NEK7 preclinical program in Q1 2024; The Company expects to nominate a development candidate for the CDK2 preclinical program in 2024."

07:56 EST Arbutus Biopharma lays out 2024 objectives, sees cash runway into Q1 of 2026 - Arbutus Biopharma (ABUS) announced its 2024 business outlook including its clinical development milestones to advance its HBV pipeline and a financial update. "As we enter 2024, our strong balance sheet and anticipated clinical trial readouts position us well towards achieving our mission of developing a functional cure for patients with cHBV. Our Phase 2a program for imdusiran, our RNAi therapeutic, consisting of three separate trials, reinforces the potential role of imdusiran as a cornerstone in a treatment regimen to functionally cure patients with cHBV. Additionally, AB-101, our oral PD-L1 inhibitor, continues to progress and we look forward to preliminary data from the ongoing Phase 1a/1b clinical trial. We remain committed to continuing discovery research in HBV and we are confident that we have the talent and resources to execute our mission," said Michael J. McElhaugh, Interim President and Chief Executive Officer of Arbutus Biopharma. "Arbutus will continue to protect and defend its intellectual property, which is the subject of the on-going lawsuits against Moderna and Pfizer/BioNTech. The Company is seeking fair compensation for Moderna's and Pfizer/BioNTech's use of its patented LNP technology that was developed with great effort and at a great expense, without which Moderna and Pfizer/BioNTech's COVID-19 vaccines would not have been successful. With respect to the Moderna lawsuit, fact discovery is currently on-going with the claim construction hearing scheduled for February 8, 2024. According to the Court Scheduling Order, which was issued on March 21, 2023, the court is expected to issue its claim construction order within 60 days of conclusion of the claim construction hearing. Expert testimony and depositions will then follow. A trial date has not been set, but the trial is expected to commence in the first half of 2025. The lawsuit against Pfizer/BioNTech is ongoing and a date for a claim construction hearing has not been set," the company said. "The Company expects to significantly reduce its net cash burn in 2024 when compared to 2023. The Company expects net cash burn in 2024 to range from $63M-$67M versus a 2023 net cash burn of approximately $85M. The Company believes its cash, cash equivalents and investments in marketable securities of approximately $132M as of December 31, 2023, are sufficient to fund its operations into the first quarter of 2026. The preliminary cash, cash equivalents and investments as of December 31, 2023 and its preliminary 2023 net cash burn were calculated prior to the completion of an audit by Arbutus' independent registered public accounting firm and are therefore subject to adjustment," the company added.

07:56 EST Ionis Pharmaceuticals announces 2024 expected milestones - Ionis Pharmaceuticals announced highlights from the Company's 2023 achievements and previewed a number of important milestones expected in 2024. In 2023, Ionis made significant progress in advancing a steady cadence of medicines for people with serious diseases, including the U.S. approval of WAINUA for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis and the accelerated approval of QALSODY for SOD-1 amyotrophic lateral sclerosis. 2024 Anticipated Highlights Include: Continued progress with WAINUA, Ionis' first co-commercialized medicine in collaboration with AstraZeneca in the U.S.: U.S. launch for ATTRv-PN in January; European Medicines Agency approval decision; additional country approvals; Additional regulatory filings for ATTRv-PN; Continuing the fully enrolled, landmark CARDIO-TTRansform trial in ATTR-cardiomyopathy, with data expected as early as 2025. Advancing olezarsen, our first anticipated independent launch: Detailed Phase 3 FCS results presentation; U.S. Food and Drug Administration regulatory filing in FCS, potential approval decision and U.S. launch; EMA filing for FCS; Completion of enrollment in severe hypertriglyceridemia Phase 3 studies, with data expected in 2025. Pivotal results and potential regulatory filing for investigational donidalorsen, our second anticipated independent launch: Phase 3 OASIS-HAE in first quarter and OASIS-Plus switch results by mid-year; Potential U.S. regulatory filing in hereditary angioedema. Advancing additional independent investigational medicines: Ionis expects to have six independent neurology programs in clinical development by year-end 2024, including new programs in rare pediatric diseases and severe dementias, which currently have no approved therapies; Phase 2 results for ION224 in nonalcoholic steatohepatitis anticipated. Continued progress with key partnered programs, including: QALSODY: EU SOD1-ALS CHMP and approval decision; ION582: Phase 1/2 clinical results in Angelman syndrome; ION541: Phase 2 results in ALS; IONIS-FB-LRx: Phase 2 results in IGA nephropathy and geographic atrophy, a serious eye disease.

07:55 EST Athira Pharma CMO Hans Moebius retires - Hans Moebius, MD, PhD, is retiring as Chief Medical Officer effective January 5, 2024, and will continue as Athira's Senior Scientific Advisor. The Company has initiated a search to fill the Chief Medical Officer position.

07:54 EST Bitfarms appoints Krumme as SVP, Head of Investor Relations - Bitfarms announced that it has appointed Tracy Krumme as Senior Vice President, SVP, Head of Investor Relations. Krumme has more than 30 years of leadership experience in investor relations, financial communications, investment banking, and equity research. She most recently led the pre-IPO process at Galderma SA.

07:53 EST Xoma appoints Owen Hughes as CEO, Jack Wyszomierski as chairman - XOMA Corporation announced the Board of Directors has named Owen Hughes as CCEO and Jack L. Wyszomierski as Chairman of the Board. Mr. Hughes has served as XOMA's Executive Chairman and Interim CEO since January 1, 2023.

07:51 EST Crispr Therapeutics announces 2024 outlook - CASGEVY: Received regulatory approvals for CASGEVY in the fourth quarter of 2023 in the U.S. for sickle cell disease and in Great Britain and Bahrain for the treatment of SCD and transfusion-dependent beta thalassemia; also received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for CASGEVY for both SCD and TDT from the European Medicines Agency. Exa-cel is the first therapy to emerge from a strategic partnership between CRISPR Therapeutics and Vertex Pharmaceuticals. Vertex leads global development, manufacturing, regulatory and commercialization of CASGEVY with support from CRISPR Therapeutics. The FDA has assigned a Prescription Drug User Fee Act action date of March 30, 2024, for CASGEVY in TDT. Additional regulatory submissions for CASGEVY are currently under review in Switzerland and the Kingdom of Saudi Arabia, with the submission in Canada planned for the first half of 2024. Completed enrollment in two global Phase 3 studies of CASGEVY in patients 5 to 11 years of age with SCD or TDT. Vertex is engaging with experienced hospitals to establish a network of authorized treatment centers throughout the U.S. to offer CASGEVY to patients. Nine ATCs have been activated in the U.S. and three in Europe, with the goal of activating approximately 50 ATCs in the U.S. and 25 in the EU. Additionally, Vertex announced an agreement with a major medication contracting organization, Synergie Medication Collective, which covers nearly 100 million lives in the U.S., to provide access to CASGEVY through an outcomes-based contract. Hemoglobinopathies CRISPR Therapeutics has two next-generation research focuses that each have the potential to expand the addressable population with SCD and TDT significantly. First, the Company continues to advance its internal targeted conditioning program, an anti-CD117 antibody-drug conjugate, through preclinical studies. Second, the Company has ongoing research efforts to enable in vivo editing of hematopoietic stem cells. This work, supported in part by a $14.5 million grant from the Bill & Melinda Gates Foundation, could obviate the need for conditioning altogether, expand geographic reach, and enable the treatment of multiple additional other diseases beyond SCD and TDT. Immuno-Oncology and Autoimmune Disease CRISPR Therapeutics' next-generation allogeneic CAR T candidates reflect the Company's mission of innovating continuously to bring potentially transformative medicines to patients as quickly as possible. Clinical trials are ongoing for CRISPR Therapeutics' next-generation CAR T product candidates, CTX112 and CTX131, targeting CD19 and CD70, respectively. Emerging pharmacology data, including pharmacokinetics, indicate that the novel potency gene edits in CTX112 and CTX131 can lead to significantly higher CAR T cell expansion and functional persistence in patients compared to the first-generation candidates. Focusing efforts on these candidates will enable the Company to advance these potentially best-in-class CAR T therapies more efficiently and rapidly. The Company expects to provide a clinical update in 2024 for these next-generation candidates. CRISPR Therapeutics plans to initiate a clinical trial of CTX112 in systemic lupus erythematosus in the first half of 2024, with the potential to expand into additional autoimmune indications in the future. Early clinical studies have shown that CD19-directed autologous CAR T therapy can produce long-lasting remissions in multiple autoimmune indications. CRISPR Therapeutics is expanding trials of CTX131 into hematologic malignancies, including T- and B-cell malignancies, in addition to the ongoing clinical trial in solid tumors. In Vivo CRISPR Therapeutics is advancing a pipeline of in vivo gene editing programs using lipid nanoparticle delivery of Cas9 mRNA and a guide RNA to the liver. Its first two in vivo programs, CTX310 and CTX320, each aim to reduce expression of a validated target for cardiovascular disease. Beginning with these programs, CRISPR Therapeutics aims to transform the treatment paradigm for cardiovascular indications and beyond with potential one-time therapies that could recapitulate the proven benefit of targets validated by natural human genetics and other therapeutic modalities. A Phase 1 clinical trial is ongoing for CTX310, targeting angiopoietin-like 3 protein. In humans, naturally occurring loss-of-function variants in ANGPTL3 are associated with reduced levels of serum lipids and reduced risk of atherosclerotic cardiovascular disease. The Phase 1 trial is enrolling patients with mixed dyslipidemias, homozygous familial hypercholesterolemia, and severe hypertriglyceridemia. CRISPR Therapeutics has initiated a Phase 1 clinical trial for CTX320, an investigational program targeting lipoprotein. Elevated Lp(a), which is associated with an increased risk of atherosclerotic cardiovascular disease, is present in approximately one in five people in the United States and around the world. CRISPR Therapeutics expects to nominate additional in vivo programs targeting both rare and common diseases this year, to be disclosed in mid-2024. Regenerative Medicine CRISPR Therapeutics announced today that ViaCyte has elected to opt-out of the collaboration with CRISPR Therapeutics for the co-development and co-commercialization of gene-edited stem cell therapies for the treatment of diabetes. Per the opt-out terms, the on-going collaboration assets will now be wholly owned by CRISPR Therapeutics, subject to a royalty on future sales owed to ViaCyte. The opt-out will become effective in early February. The ViaCyte collaboration assets include CTX211, an allogeneic, gene-edited, immune-evasive, stem cell derived product candidate that is transplanted into patients in a device and intended to produce insulin in a glucose-dependent manner. CRISPR Therapeutics continues to advance a Phase 1 clinical trial for CTX211 for the treatment of Type 1 Diabetes . CRISPR Therapeutics remains committed to its goal of developing a beta-cell replacement product that does not require chronic immunosuppression. Separate from the ViaCyte collaboration, Vertex continues to have non-exclusive rights to certain CRISPR Therapeutics' CRISPR/Cas9 technology to accelerate development of potentially curative cell therapies for T1D. Vertex paid $170 million to CRISPR Therapeutics in upfront and milestone payments in 2023 as part of that licensing agreement, and CRISPR Therapeutics remains eligible for an additional $160 million in research and development milestones and would receive royalties on any future products resulting from this agreement. Manufacturing CRISPR Therapeutics' state-of-the-art Good Manufacturing Practice facility located in Framingham, MA is fully operational, and continues to support the production of the Company's various investigational therapies. Potential benefits of this facility include significantly lower cost of goods, increased flexibility and greater scalability. The Company's next-generation allogeneic CAR T candidates manufactured at its internal GMP facility exhibit increased manufacturing robustness, yield and scalability.

07:50 EST Crocs jumps 7% to $93.03 after issuing positive guidance -

07:49 EST Cartesian announces follow-up data from Phase 2a trial of Descartes-08 - Cartesian Therapeutics (RNAC) announced positive twelve-month follow-up data from its Phase 2a trial of Descartes-08 in patients with generalized myasthenia gravis, a chronic autoimmune disorder that causes disabling muscle weakness and fatigue. The manuscript titled, "Twelve-Month Follow-Up of Patients With Generalized Myasthenia Gravis Receiving BCMA-Directed mRNA Cell Therapy," has been submitted for peer-review and can be accessed on the online preprint server, medRxiv. Data reported today are headlined by long-term results from all participants who received a once-weekly infusion for six weeks during the Phase 2a portion of the study: Descartes-08 was infused in an outpatient setting without lymphodepleting chemotherapy. Throughout the study and long-term follow-up interval, Descartes-08 was well-tolerated, with no dose-limiting toxicities, cytokine release syndrome, or neurotoxicity. At Month 9 follow-up, all participants continued to experience marked and long-lasting clinical improvements across four validated MG disease scoring systems: MG Composite, MG Activities of Daily Living, Quantitative MG scores, and Quality of Life 15-revised. These assessments occurred approximately 7 months after the last Descartes-08 infusion, and no participants received new or increased MG-directed drugs during the study period. At Month 12, five of the seven participants maintained clinically meaningful improvement in the same four scoring systems. These assessments occurred approximately 10 months after the final Descartes-08 infusion. Two participants experienced loss of clinical effect at Month 12 and were eligible for retreatment. One participant was retreated, and experienced rapid improvement in clinical scores, which was ongoing at Month 6 of follow-up with minimal symptom expression. All three participants with detectable anti-acetylcholine receptor antibody levels at baseline experienced marked anti-AChR antibody reductions by Month 6, which deepened further by Month 9, and were maintained at Month 12.

07:47 EST Shattuck Labs highlights upcoming key milestones in 2024 - "In 2023, we delivered key safety and efficacy data across our clinical development program for SL-172154 and further strengthened our financial resources, which we believe will carry us beyond upcoming milestones in the year ahead," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck Labs. "Based on preliminary results demonstrating initial anti-tumor activity and an acceptable safety and tolerability profile across several indications, we believe SL-172154 has first-in-class opportunities in HR-MDS, AML, and ovarian cancer. Our recent financing enables the expansion of our trial in HR-MDS and TP53m AML and acceleration of other regulatory and manufacturing activities to support our discussions in 2024 regarding potential registrational development plans. These are all indications with significant unmet medical need, and we will maintain our current operational efficiency and focus to drive shareholder value in the year ahead." Clinical Milestones Expected in 2024 Complete objective response rates and initial duration of response data from the ongoing Phase 1B clinical trial of SL-172154 in combination with PLD in PROC expected mid-year 2024. Initial combination data from the Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC expected mid-year 2024. Complete objective response rates and initial duration of response data from the Phase 1B expansion cohorts of SL-172154 in combination with AZA in frontline TP53m AML and HR-MDS expected mid-year 2024.

07:46 EST Option Care Health selects Palantir's AI platform for digital transformation - Palantir Technologies (PLTR) and Option Care Health (OPCH) announced a multi-year commercial partnership for Palantir's software to be leveraged across the company to help improve patient outcomes and increase efficiency. Option Care Health expects to use Palantir's Artificial Intelligence Platform across nurse scheduling, patient onboarding, purchasing optimization, and supply chain execution, among other potential use cases. "We are excited to partner with one of the innovative leaders in AI-powered software and leverage their platform and expertise to enhance our intelligent technology ecosystem focused on streamlining processes, enhancing our expertise, improving the patient experience, and optimizing clinical outcomes," said John Rademacher, President & CEO of Option Care Health. "I believe that utilizing Palantir's Foundry and AIP will allow us to innovate rapidly, build on best practices and help ensure our approach to AI and Machine Learning incorporates the strongest foundations and provides strong protections and integrity for our stakeholders."

07:43 EST Foghorn Therapeutics announces strategic objectives for 2024 - "We enter 2024 with several important milestones ahead of us. We anticipate data from our Phase 1 combination study of FHD-286 in AML in the second half of the year and look forward to continued progress with our unique pipeline, including our BRM selective inhibitor and degrader programs in collaboration with Loxo@Lilly," said Adrian Gottschalk, President and Chief Executive Officer. "We have made significant progress with our preclinical programs, including our selective EP300, CBP and ARID1B degrader programs and are getting ready to share more preclinical data in the first half of the year. This will also include preclinical combination data of FHD-286 with tyrosine kinase inhibitors of EGFR and KRAS. Over the next four years, we anticipate the filing of at least six new INDs, reflecting the productivity of our precision medicine platform. This is all supported by our cash and equivalents position of approximately $259.9 million as of September 30, 2023." FHD-286. FHD-286 is a potent, selective inhibitor of the BRG1 and BRM subunits of the BAF chromatin remodeling complex where dependency on BRG1/BRM is well-established preclinically with multiple tumor types, including acute myelogenous leukemia/myelodysplastic syndrome, non-small cell lung cancer and prostate cancer. AML Update. Foghorn commenced a Phase 1 study of FHD-286 in combination with decitabine or low-dose cytarabine in relapsed and/or refractory AML patients, with the first patient dosed during the third quarter of 2023. The first clinical data are expected in the second half of 2024. TKI Resistance. Recently published data, along with Foghorn's work, suggest that FHD-286 may play an important role in overcoming resistance in EGFR/KRAS tumors. The company is conducting preclinical work to further explore the opportunity. Differentiated Pipeline Advancement. Foghorn continues to expand its platform and pipeline. The Company anticipates the potential for six new investigational new drug applications in the next four years. The Company continues to progress programs for multiple targets that include chromatin remodeling complexes, transcription factors, helicases and other chromatin-related factors. These targets include selective BRM and wholly owned programs including CBP, EP300, and ARID1B, as well as other undisclosed targets, which combined could address more than 20 tumor types impacting more than 500,000 new patients annually. Selective EP300 and Selective CBP programs. Foghorn presented new preclinical data for its EP300 and CBP selective degrader programs at Hanson Wade's 6th Annual Targeted Protein Degradation Summit on October 31, 2023. EP300 selective degraders showed potent cellular antiproliferation and in vivo tumor growth inhibition in an AR+ enzalutamide prostate in vivo model. CBP selective degraders demonstrated significant tumor growth inhibition in a colorectal cancer in vivo model. Antiproliferative effects were also observed for numerous cancer cell lines, including colorectal, gastric and bladder cancers. At preclinical efficacious doses, neither the EP300 nor the CBP selective degraders caused thrombocytopenia, a commonly observed safety liability for dual CBP/EP300 inhibitors. Additional preclinical data will be presented in the first half of 2024. Strong Balance Sheet and Cash Runway. As of September 30, 2023, the Company had $259.9 million in cash, cash equivalents and marketable securities providing cash runway into the first half of 2026.

07:41 EST Travere Therapeutics announces anticipated 2024 milestones - FILSPARI is an endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression, generally a UPCR greater than or equal to1.5 g/g. In 2024, the Company anticipates conversion of FILSPARI from accelerated approval to full approval for IgAN as well as a potential approval for the treatment of IgAN in Europe. The Company is also generating additional data that is expected to support the clinical profile of FILSPARI and it anticipates updates to treatment guidelines for IgAN to include FILSPARI. FILSPARI - IgAN: In the fourth quarter of 2023, the Company received 459 new patient start forms, reflecting continued strength in physician demand. Preliminary net product sales of FILSPARI in the fourth quarter of 2023 were $15 million; $30 million since the beginning of commercial launch in February 2023. The Company is on track to submit a supplemental New Drug Application (sNDA) in the first quarter of 2024 for conversion of the existing U.S. accelerated approval of FILSPARI to full approval. Following submission of the two-year results from the PROTECT Study of FILSPARI in IgAN and a corresponding procedural review clock-stop, the Company and its collaborator CSL Vifor anticipate a review opinion by the Committee for Medicinal Products for Human Use on the potential approval of the Conditional Marketing Authorization application for sparsentan for the treatment of IgAN in Europe in the first quarter of 2024. If approved, sparsentan would receive CMA in all member states of the European Union, as well as in Iceland, Liechtenstein, and Norway. In 2024, the Company expects additional data from its ongoing open-label studies evaluating the safety and efficacy of sparsentan in combination with sodium glucose cotransporter-2 inhibitors as well as from the ongoing SPARTAN Study evaluating the potential effect of FILSPARI as a first-line therapy in patients with newly diagnosed IgAN. In 2024, the Company anticipates inclusion of FILSPARI into the Kidney Disease Improving Global Outcomes Clinical Practice Guideline for the Management of Glomerular Diseases. Sparsentan - Focal Segmental Glomerulosclerosis: In 2024, the Company is conducting additional analyses of FSGS data and will engage with regulators to evaluate potential regulatory pathways for a sparsentan FSGS indication. Pegtibatinase - Classical HCU: The Company is advancing pegtibatinase, a novel investigational enzyme replacement therapy with the potential to become the first and only disease-modifying therapy for people living with classical homocystinuria: In December 2023, the Company initiated the pivotal Phase 3 HARMONY Study to support the potential approval of pegtibatinase for the treatment of classical HCU. The HARMONY Study is a global, randomized, multi-center, double-blind, placebo-controlled Phase 3 clinical trial designed to evaluate the efficacy and safety of pegtibatinase as a novel treatment to reduce total homocysteine levels. The trial is expected to enroll approximately 70 patients with a diagnosis of classical HCU and tHcy levels greater than or equal to50 muM while maintaining their standard-of-care treatment. Participants will be randomized 1:1 to receive 2.5 mg/kg of pegtibatinase or placebo, administered subcutaneously, for a 24-week blinded treatment duration. The primary endpoint is relative geometric mean change in plasma tHcy levels from baseline compared to weeks 6 through 12. Durability of treatment response through 24 weeks of treatment will also be measured as a secondary endpoint. Topline results from the HARMONY Study are expected in 2026. The Company will also be initiating the ENSEMBLE Study, a Phase 3b, open-label, long-term extension, that will evaluate the ongoing efficacy and long-term safety of pegtibatinase in participants with HCU following their completion of the COMPOSE Study or the HARMONY Study. ENSEMBLE will include an optional protein tolerance modification sub-study that will evaluate if patients can increase their natural dietary protein intake and maintain an acceptable level of metabolic control while receiving pegtibatinase.

07:40 EST Masonite sees closing PGT Innovations deal in the middle of 2024 - Masonite International (DOOR) issued the following statement. "Masonite remains fully committed to the transaction with PGT Innovations (PGTI) on its current terms and is confident that the definitive merger agreement - a result of thorough due diligence and careful negotiation by both the Masonite and PGTI Boards - reflects a full and fair value for PGTI and its shareholders. In addition to compelling value, Masonite's agreement also provides a high degree of transaction certainty...Specifically, the combination of Masonite and PGT Innovations offers: Financial Benefits A compelling $33.50 in cash for PGTI shareholders plus the unique ability to participate in the powerful upside growth potential of the business with approximately 16% ownership of the combined company through the receipt of Masonite stock; Approximately 200 bps increase in future revenue growth rate and an expanded total addressable market ...Scale, resources and brand recognition provided as part of a larger, more diverse company ..The terms of the binding agreement between Masonite and PGT Innovations remain in effect, and we look forward to continued progress on all workstreams as we move toward a successful closing of the transaction in the middle of this year."

07:38 EST Travere Therapeutics sees 2023 net product sales from cont. ops. $40M - For the fiscal year 2023, the Company expects net product sales from continuing operations to be approximately $128 million. The Company ended 2023 with approximately $567 million in cash, cash equivalents, and marketable securities which is expected to support operations into 2028. The Company also provided an update on key corporate, clinical, and regulatory development initiatives, including anticipated milestones for 2024. "Our strong fourth quarter results reflect the growing demand for FILSPARI in IgAN driven by our field teams' education and outreach efforts to healthcare providers," said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. "In 2024, we are well-positioned to drive sustained growth of FILSPARI as the only non-immunosuppressive therapy for IgAN through our continued strong commercial execution and the potential conversion from accelerated to full approval. Additionally, we are pleased to have recently initiated the pivotal HARMONY Study for pegtibatinase. We are focused on building momentum for enrollment of this important trial which is designed to support the potential approval of pegtibatinase as the first and only disease-modifying therapy for classical HCU. Looking forward, we believe our efforts will ultimately position FILSPARI and pegtibatinase as new treatment standards in IgAN and classical HCU, clearly helping to address the needs of patients living with these rare diseases."

07:37 EST Johnson & Johnson to acquire Ambrx Biopharma for $2B in cash - Johnson & Johnson (JNJ) announced it has entered into a definitive agreement to acquire Ambrx Biopharma (AMAM) in an all-cash merger transaction for a total equity value of approximately $2B, or $1.9B net of estimated cash acquired. Under the terms of the transaction, which was approved by the Johnson & Johnson board of directors, Johnson & Johnson will acquire all of the outstanding shares of Ambrx's common stock for $28.00 per share in cash through a merger of Ambrx with a subsidiary of the company. The closing of the transaction is expected to occur in the first half of 2024, subject to receipt of Ambrx shareholder approval, as well as clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. The approximately $1.9 billion estimated net value of the transaction is based on Ambrx's estimated fully diluted shares outstanding, less estimated net cash at the time of closing. Following completion of the transaction, Ambrx's common stock will no longer be listed for trading on the Nasdaq Global Select Market. The accounting treatment as a business combination or asset acquisition will be determined on or before the expected close of the transaction.

07:35 EST Camping World to acquirethree locations in Texas and Oklahoma, no terms - Camping World Holdings announced that it is set to acquire Genuine RV, with locations in Texarkana and Nacogdoches, Texas, and Idabel, Oklahoma. The transaction is anticipated to close in the second quarter of 2024 and will increase the Company's Texas location count to 13, and its Oklahoma location count to six. Marcus Lemonis, Chairman and CEO of Camping World commented, "The acquisition of Genuine RV builds out our presence in East Texas, with three stores and the addition of lines from Grand Design and Keystone. We continue to be focused on our goal to increase our dealership count to over 320 locations over the next five years, through a combination of acquisitions, new store openings, and manufacturer exclusive locations."

07:34 EST Regeneron unit announces multi-national agreement with Medison Pharma - Medison Pharma announced their exclusive multi-national agreement with Regeneron Ireland DAC, a wholly owned subsidiary of Regeneron Pharmaceuticals, to commercialize Libtayo, a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells, in select European markets and additional markets around the world. Libtayo was invented in laboratories at Regeneron, which acquired exclusive worldwide development, commercialization, and manufacturing rights to the medicine from Sanofi in July 2022. Medison and Regeneron will work together with all stakeholders and regulatory authorities to facilitate a seamless transition of commercialization activities to Medison during the first half of 2024.

07:32 EST Soligenix announces FDA Fast Track designation for dusquetide - Soligenix announced that its SGX945 (dusquetide) development program for the treatment of oral lesions of Behcet's Disease has received "Fast Track" designation from the U.S. FDA.

07:30 EST Nurix Therapeutics expects cash runway into 2H25 - Maintained strong balance sheet with $329M including funds as of August 31, 2023 and $60 million upfront received from Seagen in the fourth quarter of 2023. Based on our current operating plan Nurix has cash runway into the second half of 2025.

07:29 EST Tourmaline Bio announces upcoming key milestones for TOUR006 - Tourmaline Bio announced that: It is planning to commence a pivotal Phase 3 trial for TOUR006 in TED in 2024. This second pivotal trial will replace the previously planned TED basket trial and does not impact Tourmaline's expected cash runway through 2026. Topline data from the ongoing Phase 2b spiriTED trial are expected in the first half of 2025 and topline data from the planned Phase 3 trial in TED are expected in 2026. Alignment has been reached with the U.S. Food & Drug Administration on the ASCVD clinical development program, including a Phase 2 trial evaluating the reduction of C-reactive protein, a validated biomarker for inflammation, with quarterly dosing of TOUR006 in patients with elevated cardiovascular risk. This trial is targeted to commence in the first half of 2024, with topline data expected in the first half of 2025. Pending success, the results from the Phase 2 trial are expected to position Tourmaline to be ready in 2025 to commence a pivotal Phase 3 trial in cardiovascular disease.

07:28 EST Absci to present preclinical data for ABS-101 - Absci Corporation will be presenting preclinical data for ABS-101, an anti-TL1A antibody program, this week at the 42nd Annual J.P. Morgan Healthcare Conference. Absci's Integrated Drug Creation platform designed over 50 antibody leads with subnanomolar affinity using its de novo generative AI foundation model, enabling a diversity of potential candidates. Absci has selected three potential candidates for the ABS-101 program utilizing its AI lead optimization capabilities. In preclinical studies, ABS-101 potential candidates exhibited properties consistent with a potentially superior product profile by demonstrating equal or superior potency data from multiple biophysical and cellular assays, in addition to improved developability properties, as compared to estimated performance of a putative clinical competitor molecule in later stages of development. These attributes support the program's potential to create an efficacious candidate conducive to subcutaneous dosing. Furthermore, in vitro and preliminary in vivo PK studies confirm the potential for extended half-life, supporting the objective for significantly improved dosing intervals. These preclinical results demonstrate the ability of Absci's generative AI platform to rapidly and efficiently create differentiated antibody drug candidates. Supporting data for these assessments can be found in the associated company presentation for the upcoming J.P. Morgan Healthcare Conference, published on Absci's investor relations website. Absci expects to initiate Investigational New Drug application enabling studies for ABS-101 in February 2024, and submit an IND in the first quarter of 2025. Subject to clearance of the IND, Absci expects to initiate Phase 1 studies for this program shortly thereafter.

07:28 EST Citi Trends announces results for holiday selling period - Citi Trends announced results for its holiday selling period. Total sales for the quarter-to-date period ending January 6 of $179.5M compared to $181.9M in the same period in 2022. Comparable store sales for the quarter-to-date period ending January 6 were down -0.3% versus the same period in 2022. David Makuen, CEO, said, "I am pleased to report that our holiday sales were at the high end of our expectations as our Ready. Set. GIFT! Campaign resonated well with the families we serve. Our nearly flat comp was driven by strategic inventory investments while continuing to generate strong gross margin. Importantly, our holiday sales results represent a significant trend change to the prior quarter with an improvement in comp sales performance of approximately 600 basis points."

07:27 EST Solaris Resources provides 2024 preview, including planned NYSE American listing - Solaris Resources announced a preview of its 2024 plans for the Company and its Warintza Project in southeastern Ecuador. Key Milestones: NYSE American Listing - The Company intends to list on the NYSE American stock exchange to satisfy the appetite of many U.S. retail and institutional investors seeking to add exposure to Solaris. In advance of listing on the NYSE American, Solaris will file a Form 40-F Registration Statement with the United States Securities and Exchange Commission. Subject to the review and approval of the listing application and satisfaction of all applicable listing and regulatory requirements, the Company expects its common shares to commence trading on the NYSE American in H1/24. Mineral Resource Update in Q2/24 - The Company is nearing the completion of its second phase of mineral resource drilling at Warintza, which is expected to nearly double the meterage available for inclusion in the updated mineral resource estimate and deliver major growth through expansion of the deposit in extensional drilling at Warintza Central and Warintza East, and through the inclusion of the recent discovery of Warintza Southeast within a common pit shell. Extension and Infill Drilling - The third phase of drilling at Warintza is set to commence imminently and includes extensional drilling in areas in which the Warintza East and Warintza Southeast deposits are still open, and approximately 30km of infill drilling to further delineate and define mineral resources within the pit shell in advance of studies, with some of these holes doubling to provide technical data for mine design and mine planning purposes. Warintza Exploration - Plans include following up on the recent Patrimonio discovery, where the first reconnaissance holes intercepted 144m of 0.50% CuEq and 148m of 0.52% CuEq, respectively. Notably, these intercepts included skarn mineralization for which the source has not yet been located. Vectors for this mineralization trend northwest and are untested for over 1km toward Warintza West while the strongest soil geochemical anomalism is untested in the southern part of Patrimonio. In addition, the Company plans to revisit the El Trinche area that forms the southern, low grade margin of Warintza Central where a near surface intercept of high-grade mineralization within a broader low grade interval has been interpreted as a dyke with veinlet orientations and alteration suggesting it may form a high level expression of a potentially deeper, higher grade system that has not yet been located. Regional Exploration - Field investigation is planned to define drill targets at prospective areas identified in the regional exploration program to date, including: Medio Camino: a 3.5km x 1.5km porphyry target defined in soil geochemical data roughly equidistant between the Warintza porphyry cluster to the east and the neighboring San Carlos - Panantza porphyry cluster to the west; Clemente: a series of porphyry targets on trend to the north of the San Carlos - Panantza porphyry cluster; Mateo: a 3km x 1.4km area of copper-molybdenum enrichment in soil samples approximately 5km east of Warintza East that is expressed around the perimeter of an overlapping sandstone unit that may cover a porphyry; Caya: a 5km x 3km gold anomaly in stream sediments 6km northeast of Warintza East, where follow-up sampling has identified an area of 0.7km x 1.3km of anomalous gold, copper and epithermal pathfinder element values, and a concentration of dickite clay and vuggy silica alteration minerals characteristic of high sulphidation epithermal systems. Studies - The Company anticipates finalizing and submitting the Environmental Impact Assessment for the Warintza Project for regulatory review and approval in H2/24, after more than three years of baseline environmental monitoring, data collection and studies from prior permitting efforts. Follow-up programs for metallurgy, geotechnical and hydrogeological drilling, together with detailed access, internal/external infrastructure, and water and power studies will proceed under the direction of Javier Toro, recently appointed as Chief Operating Officer, and run through the end of the year.

07:26 EST Canadian Solar unit to deliver 220 MWh DC of energy storage to Mannum project - Canadian Solar announced that e-STORAGE, which is part of the company's majority-owned subsidiary CSI Solar Co., Ltd., will deliver 220 MWh DC of energy storage solutions to a standalone energy storage project owned by Epic Energy in Mannum, South Australia. The Mannum project is being developed by Canadian Solar through its wholly-owned subsidiary Recurrent Energy. e-STORAGE will begin construction on the Mannum project in the second quarter of 2024.

07:25 EST ProMIS Neurosciences issues letter to shareholders - ProMIS Neurosciences announced that its Chief Executive Officer, Neil Warma, issued the following letter to the Company's shareholders. "As part of our commitment to becoming a leader in the treatment of dementias, we are intensifying our focus on advancing our drug candidates into and through clinical development. Our ultimate goal is to get these potential new drugs to patients who are in desperate need of safe and effective treatment options. ProMIS' scientific platform is truly unique... Our belief is that if you can specifically target only the harmful or pathogenic proteins, this should result in a beneficial outcome to the patient and with fewer side effects. Our wealth of preclinical data demonstrates this, and we are hopeful the clinical data will continue to support this belief. I am pleased to share that our lead clinical drug candidate, PMN310, is progressing well through Phase 1a clinical development for the treatment of Alzheimer's disease... We believe PMN310 holds immense promise to address the urgent need for effective treatments in AD and remains unique in its ability to specifically target only misfolded forms (i.e., toxic oligomers) of amyloid-beta, which are believed to drive disease progression in AD... We remain committed to advancing PMN310 through the rigorous clinical development process. Over the coming months, we will be laser-focused on completing the SAD clinical study with PMN310 and, subsequently, rolling into the Phase 1b Multiple Ascending Dose study, subject to the availability of sufficient capital. As the Phase 1b MAD study will be conducted in AD patients, this could provide the first signal demonstrating that PMN310 positively benefits patients with AD. We expect to report data on the Phase 1a study around mid-2024... In line with our commitment to collaboration and growth, we are aggressively pursuing partnering discussions to leverage synergies and enhance our capabilities... We truly believe that we have a powerful technology platform from which multiple drug candidates could be developed and we are diligent in identifying ways to untap this potential while not distracting our focus from the lead development program with PMN310 and our tight control on cash management... In summary, I am honored to be representing you as ProMIS' interim CEO. Our priorities are clear: to advance PMN310 through clinical development; to increase the Company's visibility to better highlight the significant value of ProMIS; to advance strategic partnering discussions; and to effectively allocate and manage cash. We remain committed to our goal of generating shareholder value and improving the lives of patients worldwide. Finally, I want to express my deepest gratitude for your ongoing support as shareholders.... As we navigate this transformative period, I am confident that ProMIS will emerge stronger, more resilient, and better positioned to make significant contributions to healthcare. We are on an exciting journey, and I look forward to sharing more successes with you in the future."

07:24 EST Quest Diagnostics unit, Alliance Foundation Trials enter collaboration - Haystack Oncology, a Quest Diagnostics (DGX) company, has entered into a collaboration with Alliance Foundation Trials for research use of Haystack Oncology's personalized MRD technology (Haystack MRD(TM)) to analyze therapeutic response and provide molecular insights for AFT's interventional, randomized phase II clinical trial (AFT-57) in patients with unresectable stage III non-small cell lung cancer. The AFT-57 clinical study is supported by Genentech, a member of the Roche Group (RHHBY), and will explore the efficacy and safety of an anti-PD-L1 atezolizumab with or without tiragolumab in conjunction with chemoradiotherapy.

07:22 EST Mural Oncology announces enhancements to late-stage clinical trials - Mural Oncology announced strategic changes to its ARTISTRY-6 and ARTISTRY-7 clinical trials designed to generate more meaningful clinical data for these late-stage, potentially registrational trials of nemvaleukin. These changes are as follows: Cohort 2 of ARTISTRY-6 is a potentially registrational, phase 2 trial evaluating nemvaleukin as a monotherapy in mucosal melanoma patients. Mural plans to increase the size of this cohort by approximately 16 patients and expects a top-line data readout in the first half of 2025. ARTISTRY-7 is a potentially registrational, phase 3 trial evaluating nemvaleukin as a monotherapy and in combination with pembrolizumab in patients with platinum-resistant ovarian cancer. Mural plans to increase the trial by approximately 56 patients and to change the primary endpoint of the trial from progression free survival to overall survival, which Mural believes is a more clinically meaningful outcome and one typically preferred by both regulators and payers. An OS endpoint may also better capture the effects of an IO doublet combination therapy as compared to a PFS endpoint. Mural projects an interim OS readout in the first quarter of 2025 based on approximately 75% of events and a final OS readout in the second quarter of 2026.

07:21 EST Joby enters pact with Clay Lacy Aviation to install electric air taxi charger - Joby Aviation announced it has signed a definitive agreement with Clay Lacy Aviation to install Southern California's first electric air taxi charger at John Wayne Airport, or SNA, in Orange County, California. The installation of electrical infrastructure to support Joby's Global Electric Aviation Charging System, or GEACS, comes as part of Clay Lacy's planned $100M redevelopment of its fixed-based operator, or FBO, terminal at SNA, targeting completion in mid-2025. The GEACS charging interface, which is already in use at Joby's flight test center in Marina, California and at Edwards Air Force Base, supports the safe and efficient operation of all electric aircraft under development today, including Joby's quiet, emissions-free air taxi. The Joby aircraft will be deployed on routes of up to 100 miles, and can carry a pilot and four passengers at speeds of up to 200 mph, offering travelers high-speed mobility with no in-flight emissions and a noise footprint that is radically lower than today's helicopters. The installation of a charger at John Wayne Airport will establish the site as a node in Joby's Southern California air taxi network, which is expected to be one of the first networks to launch in the U.S.

07:19 EST Okyo Pharma's OK-101 achieved statistical significance for two endpoints - OKYO Pharma reports positive safety and efficacy results in its Phase 2, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 ophthalmic solution in subjects with DED. This first-in-human trial of OK-101 established a clear and informed path for further development in Phase 3 registration trials. The double-masked, randomized, placebo-controlled Phase 2 trial was conducted at six sites in the U.S. and enrolled 240 subjects with DED dosed twice-daily. Highlights of OK-101 Phase 2 Trial: OK-101 demonstrated superiority when compared to placebo in the sign endpoint of total conjunctival staining as measured by the Ora Calibra Staining Scale as early as Day 29. OK-101 demonstrated superiority when compared to placebo across at least two symptoms of DED including burning measured by the Ora Calibra 4-symptom questionnaire as well as burning/stinging measured by a visual analogue scale as early as Day 15. A statistically significant improvement in blurred vision was also achieved at Day 29. Treatment emergent adverse events were observed to be similar to the placebo-treated group. No severe drug related ocular TEAEs were seen. Possible drug-related TEAEs were observed in one patient in the OK-101 0.05% treatment group and 3 patients in the placebo-treated group, again highlighting the favorable safety profile of OK-101. Additionally, fewer subjects in the OK-101 treated arm discontinued study medication compared to discontinuations in the placebo treated patients.

07:19 EST Regenxbio: Sarepta granted summary judgment on invalidity in patent suit - Regenxbio (RGNX) announced the U.S. District Court for the District of Delaware granted Sarepta Therapeutics (SRPT) summary judgment on invalidity in a patent infringement suit arising from Sarepta's manufacture and use of cultured host cell technology covered by a University of Pennsylvania patent that Sarepta uses to make clinical and commercial supplies of SRP-9001, for itself and Roche (RHHBY), for the treatment of Duchenne muscular dystrophy. REGENXBIO intends to file an immediate appeal. REGENXBIO exclusively licensed the patent, U.S. Patent No. 10,526,617 ('617), from Penn, which is a joint plaintiff in the lawsuit. The lawsuit was filed September 30, 2020, and a trial was scheduled for the end of January 2024. The ruling on this expired patent does not impact REGENXBIO's current licenses or therapeutic pipeline.

07:16 EST Compugen to receive $10M milestone payment from AstraZeneca - Compugen (CGEN) announced that it is entitled to receive a $10M milestone payment from AstraZeneca (AZN) after the first patient was dosed in AstraZeneca's ARTEMIDE-Bil01 trial with rilvegostomig. Rilvegostomig is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical-stage anti-TIGIT antibody, COM902. The ARTEMIDE-Bil01 trial is expected to recruit about 750 subjects in more than 20 countries with biliary tract cancer who will be randomized to receive rilvegostomig or placebo with investigator choice chemotherapy as adjuvant treatment after resection with curative intent.

07:14 EST Palantir, Option Care Health announce multi-year commercial partnership - Palantir Technologies (PLTR) and Option Care Health (OPCH) announced a multi-year commercial partnership for Palantir's software to be leveraged across the company to help improve patient outcomes and increase efficiency. Option Care Health expects to use Palantir's Artificial Intelligence Platform across nurse scheduling, patient onboarding, purchasing optimization, and supply chain execution, among other potential use cases.

07:13 EST Axonics to be acquired by Boston Scientific for $71 per share - Axonics (AXNX) announced that it has entered into a definitive agreement to be acquired by Boston Scientific (BSX) for $71 in cash per share, representing an equity value of approximately $3.7B. Axonics brings a complementary product portfolio to the Boston Scientific Urology business. Axonics has pioneered and introduced significant enhancements to sacral neuromodulation therapy for bladder and bowel dysfunction and urethral bulking for women with stress urinary incontinence, both of which are among the fastest growing segments in urology. The boards of directors of Axonics and Boston Scientific have unanimously approved the transaction, which is expected to close in the first half of 2024 after satisfaction of customary closing conditions, including approval of Axonics' stockholders and receipt of required regulatory approvals. Upon completion of the transaction, Axonics will become a wholly owned subsidiary of Boston Scientific.

07:11 EST Avadel Pharmaceuticals provides update on LUMRYS launch performance - Launch Progress Through December 31, 2023: Greater than 1,900 patients enrolled in Avadel's RYZUP patient support services: More than 1,000 patients initiated therapy. The majority of RYZUP enrollments and patients currently being treated with LUMRYZ are patients who switched from first generation oxybates, with the balance made up of patients who previously tried and discontinued a first generation oxybate and patients who are new to oxybate treatment.Signed contract with Emisar; Contracts now in place with all 3 PBM owned GPOs; LUMRYZ moved to preferred status within the CVS commercial formularies and Optum Select as of January 1, 2024. Nearly 1,800 health care providers have completed the LUMRYZ REMS certification process, including both experienced oxybate prescribers as well as providers who have never previously prescribed an oxybate.

07:10 EST Avadel Pharmaceuticals sees FY23 net product revenue $28M - Approximately $19 million and $28 million of net product revenue, respectively, estimated for the quarter and year ended December 31, 2023. Net product revenue consists of LUMRYZ product sales, which was launched in the U.S. on June 5, 2023. Approximately $105 million of cash, cash equivalents and marketable securities at December 31, 2023. "2023 was transformational for Avadel defined by significant growth and continued execution of milestones critical to Avadel's success, beginning with the FDA approval and receipt of Orphan Drug Exclusivity for LUMRYZ. The LUMRYZ launch has thus far been marked by robust demand and overwhelmingly positive feedback from the narcolepsy community, health care providers and payers. Our team is proud of the momentum built this year, and looking toward 2024, we are excited to see LUMRYZ's continued impact across the narcolepsy community," said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals.

07:08 EST Dutch Bros COO Brian Maxwell to transition to vice chairman role - Dutch Bros reported highlights for the quarterly and annual periods ended December 31, 2023. The company also released shop opening guidance for 2024, announced senior leadership changes that underscore its commitment to building a team to drive scale and support its long runway for growth, and announced its participation at the 2024 ICR Conference. The company opened 37 new shops in the fourth quarter of 2023, of which 32 were company-operated. The company opened 159 new shops in the full year 2023, of which 146 were company-operated. As of December 31, 2023, the Dutch Bros system consisted of 831 shops across 16 states. Total system shop openings are expected to be at least 150-165 in FY24. The company plans to welcome three new leaders in the coming months: Joshua Guenser as incoming CFO on or about February 19; Sumitro Ghosh as incoming president of operations on or about January 15 and Jess Elmquist as chief people officer on January 8. The company expects that, following these leadership transitions, longtime Dutch Bros executive Brian Maxwell, currently COO, will transition into the role of vice chairman, reporting to co-founder and executive chairman, Travis Boersma, subject to his appointment by the board of directors.

07:06 EST Potbelly sees Q4 SSS up 5.9%-6.4% - Sees systemwide sales up 11%-11.5%. Sees average weekly sales $24,870 to $24,970.

07:04 EST Boston Scientific to acquire Axonics for $71 per share in cash, or $3.4B EV - Boston Scientific (BSX) announced it has entered into a definitive agreement to acquire Axonics (AXNX), a publicly traded medical technology company primarily focused on the development and commercialization of differentiated devices to treat urinary and bowel dysfunction. The purchase price is $71 in cash per share, reflecting an equity value of approximately $3.7B and an enterprise value of approximately $3.4B. Boston Scientific expects to complete the transaction in the first half of 2024, subject to customary closing conditions. Axonics expects to deliver net revenue of approximately $366M in 2023, representing 34% growth over the prior fiscal year. Axonics' revenue growth profile is anticipated to be highly accretive to the Boston Scientific Urology business in 2024. The impact to Boston Scientific adjusted earnings per share is expected to be immaterial in 2024 and accretive thereafter. The impact to GAAP earnings per share is expected to be less accretive, or more dilutive, due to amortization expense and acquisition-related net charges.

07:01 EST Novartis announces its Phase III ASC4FIRST trial met both primary endpoints - Novartis announced positive results from the primary analysis of ASC4FIRST, a Phase III trial comparing Scemblix with investigators' choice of tyrosine kinase inhibitor treatment in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. ASC4FIRST is the first and only randomized head-to-head Phase III trial comparing a CML treatment vs. approved standard-of-care first- and second-generation TKIs. The trial met both primary endpoints of major molecular response rate for Scemblix compared to investigator-selected TKIs and compared to imatinib, demonstrating clinically meaningful and statistically significant results for both endpoints. Scemblix showed a favorable safety and tolerability profile with fewer adverse events and treatment discontinuations vs. investigator selected standard-of-care TKIs1. The ASC4FIRST data showed no new safety signals compared to the established safety profile of Scemblix. The trial remains ongoing, with the next scheduled data readout planned for week 96, which will evaluate the key secondary endpoint as well as additional secondary endpoints.

07:00 EST Bausch + Lomb announces FDA approval of TENEO Excimer Laser Platform - Bausch + Lomb announced the U.S. FDA has approved the TENEO Excimer Laser Platform for laser-assisted in situ keratomileusis vision correction surgery for myopia and myopic astigmatism.

06:54 EST Commercial Metals says ex-items adjusted EBITDA should improve - Matt said, "Margins on steel products are likely to experience some further compression during the second quarter, however, recent price announcements should support an inflection and improved margins going forward. Downstream product margins should exhibit good sequential stability. Conditions in Europe are expected to remain challenging, but adjusted EBITDA excluding energy rebates should improve from the levels of the past two quarters. Financial results for our Emerging Businesses Group are anticipated to follow a typical seasonal pattern. :ooking beyond the second quarter, we expect robust spring and summer construction activity driven by increased infrastructure investments, which should support an already strong demand backdrop in both the North America Steel Group and the Emerging Businesses Group. Regarding the Europe Steel Group, we expect that supply side adjustments and the impact of increasing levels of residential and infrastructure construction should drive sequential improvements in financial results beginning in the spring construction season."

06:44 EST EnPro names Joseph Bruderek Jr. as CFO, effective April 1 - Enpro announced that Joe Bruderek has joined the company as Executive Vice President, Finance, and Enpro's board has appointed Bruderek as CFO, effective April 1. His appointment follows the previously announced retirement of J. Milton "Milt" Childress II from Enpro following 19 years with the company. Childress will continue as Enpro's CFO until April 1, and will remain with the company until May 31, 2024, to ensure a smooth transition.

06:40 EST CalAmp names Chris Adams as President and CEO - CalAmp is pleased to announce that Chris Adams will be joining the company as President and CEO, effective January 22, 2024. Adams started his career in engineering and engineering leadership and has served in general management roles for more than 20 years. Prior to his current role at onsemi, Adams held business unit leadership roles with LSI Logic, Sony Electronics, and BAE Systems.

06:15 EST Verisk Analytics: CDI approves ISO wildfire mitigation filings for homeowners - Verisk announced that the California Department of Insurance has approved its ISO wildfire mitigation filings for homeowners, dwelling, commercial property, commercial inland marine and business owners programs. This critical filing enables insurers to incorporate and reflect specific wildfire mitigation discounts in their rating plans, as mandated by a CDI regulation implemented last year. Verisk has been engaging with CDI to assist insurers in responding to the mitigation regulation and navigating the changing environmental landscape. As the climate science progresses and more insurance industry data becomes available, Verisk will continue to assess the impact of mitigation for insurers. This proactive approach has positioned Verisk as an industry leader, being among the first to have its filings approved.

06:11 EST Zura Bio names Robert Lisicki as COO, Kiran Nistala as CMO - Zura Bio (ZURA) announced the appointments of Robert Lisicki as President and COO, and Kiran Nistala, MBBS, PhD, as Executive Vice President Development and Chief Medical Officer, to the Executive Leadership Team. Lisicki will be responsible for developing and driving the business plan and strategic initiatives as Zura Bio builds a leading immunology company. Dr. Nistala will be responsible for the development strategy of prioritized pipeline products. Lisicki and Dr. Nistala have successfully worked on or led in the development of multiple drugs within the auto-immune therapeutic area. These executives position Zura Bio to deliver on the promise of their innovative medicines for patients in need of better clinical outcomes. . Lisicki served as the Chief Commercial Officer at Arena Pharmaceuticals, a prominent biopharmaceutical company acquired by Pfizer (PFE) for $6.7B in 2022. Dr. Nistala recently held the role of Vice President of late-stage clinical development in Immunology at AstraZeneca (AZN), where he was instrumental to their therapeutic build in autoimmune disease.

06:07 EST Comstock Mining acquires, retires over 2.6M common shares - Comstock announced that it has reacquired and cancelled 2,605,322 of its previously issued common shares held by LINICO Corporation, and reduced Comstock's outstanding shares to 115,256,759.

06:06 EST InterDigital awarded injunction against OPPO, Realme and OnePlus - InterDigital announced it has been awarded an injunction against OPPO, Realme and OnePlus by a court in Germany. The Regional Court Munich I ruled that OPPO, Realme and OnePlus infringe InterDigital's 5G patent-in-suit, that InterDigital has acted in a FRAND manner, and that OPPO, Realme and OnePlus are unwilling licensees who have not acted in line with widely recognized FRAND principles. "This resounding victory is another example of the quality of our innovation and our leadership in licensing standardized technologies such as 5G," commented Josh Schmidt, Chief Legal Officer, InterDigital. "Having been determined to be an unwilling licensee by the court in Munich we urge OPPO to now meaningfully engage in negotiations and to take a fair and reasonable license to our patented innovation."

05:48 EST Qiagen receives FDA clearance for NeuMoDx CT/NG Assay 2.0 - Qiagen announced the FDA clearance for the NeuMoDx CT/NG Assay 2.0, growing its test menu for its integrated PCR-based clinical molecular testing systems NeuMoDx 96 and 288 in the United States. This assay is designed for direct detection of asymptomatic and symptomatic bacterial infections involving Chlamydia trachomatis, or CT, and / or Neisseria gonorrhoeae, or NG - the most common type of bacterial infection among sexually transmitted infections, according to the U.S. National Institutes of Health.

05:41 EST Calliditas Therapeutics provides business update ahead of conference - Calliditas Therapeutics provided a business update for the fourth quarter of 2023 and certain preliminary, unaudited key financial information for the fourth quarter and full year 2023, as follows: Q4 preliminary product revenue growth with net Tarpeyo revenues of $31M-$33M for the quarter, representing growth over Q3. Preliminary net Tarpeyo revenues of $100M-$102M for 2023, representing over 170% year over year growth compared to 2022. Preliminary total revenues reaching $110M-$113M for 2023, as a result of milestone payments and royalty income from the Nefecon franchise outside the U.S. Record quarter in terms of enrollments with 555 new Tarpeyo prescriptions in the fourth quarter. The information above reflects our preliminary estimates with respect to such results based on currently available information. We have provided ranges, rather than specific amounts, for the preliminary results described above primarily because our financial closing procedures are not yet complete and, as a result, our final results may vary from the preliminary estimates.

05:28 EST Fisker names Angel Salinas chief accounting officer - Fisker announced that Angel Salinas has been named chief accounting officer, effective immediately. Salinas will report to CFO Geeta Gupta-Fisker. Salinas comes to Fisker after more than two decades at PricewaterhouseCoopers, most recently as an Assurance Partner, where he served as audit signing partner on numerous clients and oversaw audit teams in the United States, Canada, India, Mexico, and Argentina. Throughout his career at PwC, Salinas has focused on complicated audit, compliance, and regulatory matters, leading large teams of accounting professionals. Salinas currently holds a CPA in Texas and Colorado and is a graduate of the University of Houston. In connection with his new appointment at Fisker, Salinas has relocated from Texas to California.

05:15 EST Arthur J. Gallagher acquires Koberich Financial Lines, terms undisclosed - Arthur J. Gallagher announced the acquisition of Cologne, Germany-based Koberich Financial Lines. Terms of the transaction were not disclosed. Koberich is an insurance broker specializing in financial lines products. Harald Koberich and his team will operate under the direction of Alex Nagler, head of Gallagher's retail property/casualty brokerage operations in Europe.